Trial Outcomes & Findings for A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma (NCT NCT02257567)

Last Updated: 2022-11-14

Results Overview

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the National Cancer Institute Common Terminology Criteria for AEs, version 4.0 (NCI-CTCAE, v4.0).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

331 participants

Primary outcome timeframe

From the study start up to the end of the study (up to approximately 84 months)

Results posted on

2022-11-14

Participant Flow

A total of 331 participants with relapsed or refractory (R/R) follicular lymphoma (FL) or diffuse large B cell lymphoma (DLBCL) were enrolled in this study at 56 investigative sites in the following countries: Australia, Canada, Czech Republic, France, Germany, Hungary, Italy, Korea, the Netherlands, Spain, Turkey, United Kingdom, and the United States from 15 October 2014 to 21 October 2021.

Participants were enrolled in Phase Ib and Phase II to receive polatuzumab vedotin (pola) (liquid formulation in randomized \& expansion stages; lyophilized formulation in new formulation (NF) cohorts) in combination with standard doses of bendamustine (B) \& rituximab (R)/obinutuzumab (G). Out of 331 participants, 327 participants received at least one dose of study drug and their intended treatment.

Participant milestones

Participant milestones
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL Participants with FL received pola, 1.8 milligrams per kilogram (mg/kg), as intravenous (IV) infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 milligrams per meter-squared (mg/m\^2), as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm A (Phase II Randomization): Pola+BR in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm B (Phase II Randomization): BR in FL Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm C (Phase II Randomization): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm D (Phase II Randomization): BR in DLBCL Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
Overall Study STARTED	6	6	6	6	39	41	40	40	20	21	106
Overall Study Safety Population	6	6	6	6	38	41	39	39	20	20	106
Overall Study COMPLETED	4	4	2	1	20	22	6	2	16	0	30
Overall Study NOT COMPLETED	2	2	4	5	19	19	34	38	4	21	76

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL Participants with FL received pola, 1.8 milligrams per kilogram (mg/kg), as intravenous (IV) infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 milligrams per meter-squared (mg/m\^2), as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm A (Phase II Randomization): Pola+BR in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm B (Phase II Randomization): BR in FL Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm C (Phase II Randomization): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm D (Phase II Randomization): BR in DLBCL Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
Overall Study Adverse Event	0	0	0	1	1	0	0	0	1	0	0
Overall Study Death	2	2	2	4	15	11	26	30	2	18	65
Overall Study Lost to Follow-up	0	0	0	0	2	2	0	0	0	1	1
Overall Study Not treated/Per Sponsor Participant Could not Continue/Pathology Showed Transformation: Cycle 1Day 1	0	0	0	0	1	0	2	0	0	0	0
Overall Study Physician Decision	0	0	0	0	0	0	0	2	0	1	0
Overall Study Withdrawal by Subject	0	0	2	0	0	6	6	6	1	1	10

Baseline Characteristics

A Study of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab Plus Bendamustine in Participants With Relapsed or Refractory Follicular or Diffuse Large B-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm A (Phase II Randomization): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm B (Phase II Randomization): BR in FL n=41 Participants Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm C (Phase II Randomization): Pola+BR in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm D (Phase II Randomization): BR in DLBCL n=40 Participants Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm E (Phase II Expansion): Pola+BG in FL n=20 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Total n=331 Participants Total of all reporting groups
Age, Continuous	68.0 years n=5 Participants	65.0 years n=7 Participants	63.5 years n=5 Participants	71.0 years n=4 Participants	65.0 years n=21 Participants	63.0 years n=8 Participants	67.0 years n=8 Participants	71.0 years n=24 Participants	60.5 years n=42 Participants	65.0 years n=42 Participants	70.0 years n=42 Participants	67.0 years n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	18 Participants n=21 Participants	23 Participants n=8 Participants	12 Participants n=8 Participants	15 Participants n=24 Participants	10 Participants n=42 Participants	10 Participants n=42 Participants	54 Participants n=42 Participants	151 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants	18 Participants n=8 Participants	28 Participants n=8 Participants	25 Participants n=24 Participants	10 Participants n=42 Participants	11 Participants n=42 Participants	52 Participants n=42 Participants	180 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	4 Participants n=24 Participants	1 Participants n=42 Participants	6 Participants n=42 Participants	8 Participants n=42 Participants	30 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	7 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	33 Participants n=21 Participants	33 Participants n=8 Participants	26 Participants n=8 Participants	31 Participants n=24 Participants	16 Participants n=42 Participants	15 Participants n=42 Participants	83 Participants n=42 Participants	259 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=8 Participants	5 Participants n=8 Participants	4 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	14 Participants n=42 Participants	34 Participants n=42 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	14 Participants n=42 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	6 Participants n=4 Participants	34 Participants n=21 Participants	34 Participants n=8 Participants	35 Participants n=8 Participants	36 Participants n=24 Participants	16 Participants n=42 Participants	19 Participants n=42 Participants	87 Participants n=42 Participants	285 Participants n=42 Participants
Race/Ethnicity, Customized Not Stated	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	13 Participants n=42 Participants	22 Participants n=42 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	10 Participants n=42 Participants

PRIMARY outcome

Timeframe: From the study start up to the end of the study (up to approximately 84 months)

Population: Safety population consisted of all ITT participants from Phase Ib who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: Percentage of Participants With Adverse Events (AEs)	100 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Month 37 to Month 84 (up to approximately 47 months)

Population: Safety population consisted of all ITT participants from Arms G+H (Phase II NF Cohort) who received at least one dose of study medication.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G+H (Phase II NF Cohort): Percentage of Participants With AEs	—	—	99.1 percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to approximately Month 24

Population: Safety population consisted of all ITT participants from Cohort 1a (Phase Ib) who received at least one dose of study medication.

The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 titer unit (t.u.) greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin Baseline Prevalence of ADAs	33.3 percentage of participants	—	50.0 percentage of participants	—	—	—	—	—	—	—
Cohort 1a (Phase Ib): Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Polatuzumab Vedotin Post-Baseline Incidence of ADAs	33.3 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Baseline up to approximately Month 24

Population: Safety population consisted of all ITT participants from Cohort 1b (Phase Ib) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.

The number of participants with positive results for ADA against pola and obinutuzumab at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab Baseline Prevalence of ADAs to Polatuzumab vedotin	0 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—
Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab Post-Baseline Incidence of ADAs to Polatuzumab vedotin	0 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—
Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab Baseline Prevalence of ADAs to Obinutuzumab	0 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—
Cohort 1b (Phase Ib): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab Post-Baseline Incidence of ADA to Obinutuzumab	0 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: From Month 37 to Month 84 (up to approximately 47 months)

Population: Safety population consisted of all ITT participants from Arm G+H (Phase II NF cohort) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

The number of participants with positive results for ADA against lyophilized pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=62 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=41 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized) Baseline Prevalence of ADAs to Polatuzumab	1.6 percentage of participants	—	0.0 percentage of participants	—	—	—	—	—	—	—
Arms G+H: (Phase II NF Cohorts): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin (Lyophilized) Post-Baseline Incidence of ADAs to Polatuzumab	5.0 percentage of participants	—	2.6 percentage of participants	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

Population: ITT population included all randomized participants in Phase II Randomized and NF cohorts irrespective of whether or not they received the study treatment.

CR was assessed by IRC at PRA according to Modified Lugano Response Criteria (MLRC). Per MLRC, CR based on PET-CT was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites (ELS) with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS) where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, immunohistochemistry (IHC) negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II Randomized and NF Cohorts: Percentage of Participants With Complete Response (CR) at Primary Response Assessment (PRA) Based on Positron Emission Tomography (PET)-Computed Tomography (CT) Scan as Determined by Independent Review Committee (IRC)	63.4 percentage of participants Interval 46.94 to 77.88	42.5 percentage of participants Interval 27.04 to 59.11	69.2 percentage of participants Interval 52.43 to 82.98	17.5 percentage of participants Interval 7.34 to 32.78	39.6 percentage of participants Interval 30.25 to 49.59	—	—	—	—	—

PRIMARY outcome

Timeframe: 6-8 weeks after Cycle 6, Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

Population: ITT population included all randomized participants in Arm H (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=64 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm H (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC	—	—	42.2 percentage of participants Interval 29.94 to 55.18	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks

Population: PK population included all ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.

Pharmacokinetic (PK) of three pola-related analytes: antibody conjugated monomethyl auristatin E (acMMAE), total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is nanograms\*day per milliliters.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=32 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized) acMMAE	—	—	2880 ng*day/mL Geometric Coefficient of Variation 0.15	—	—	—	—	—	—	—
Arm G (Phase II NF Cohort): Area Under Concentration-Time Curve (AUC) of Polatuzumab Vedotin (Lyophilized) MMAE	—	—	21.6 ng*day/mL Geometric Coefficient of Variation 45	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

Population: PK evaluable population included all the ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at the specified time point.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=32 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized) acMMAE	—	—	724 nanograms per milliliters (ng/mL) Geometric Coefficient of Variation 10	—	—	—	—	—	—	—
Arm G (Phase II NF Cohort): Maximum Concentration (Cmax) of Polatuzumab Vedotin (Lyophilized) MMAE	—	—	2.01 nanograms per milliliters (ng/mL) Geometric Coefficient of Variation 38	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

Population: As pre-specified in the protocol the analysis of this outcome measure (OM) was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. Unit of measure for CL is milliliters per day per kilograms (mL/day/kg)

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

Population: As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From the study start up to the end of the study (up to approximately 84 months)

Population: Safety population consisted of all ITT participants from Phase II who received at least one dose of study medication.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. AEs were reported based on the NCI-CTCAE, v4.0. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=38 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=39 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=20 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With AEs	100 percentage of participants	100 percentage of participants	100 percentage of participants	97.4 percentage of participants	100 percentage of participants	100 percentage of participants	99.1 percentage of participants	—	—	—

SECONDARY outcome

Timeframe: Baseline to approximately Month 24

Population: Safety population consisted of all ITT participants from Arms A and C (Phase II) who received at least one dose of study medication. 'Overall Number Analyzed' is the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

The number of participants with positive results for ADA against pola at Baseline and at any of the post-baseline assessment time-points were reported. Participants positive at any post-baseline time points were post-baseline evaluable participants determined to have "Treatment-induced ADAs" or "Treatment-enhanced ADA" during the study period. Treatment-induced ADA = negative or missing baseline ADA result(s) and at least one positive post-baseline ADA result. Treatment-enhanced ADA = a participant with positive ADA result at baseline who has one or more post-baseline titer results that are at least 0.60 t.u. greater than the baseline titer result. Treatment emergent ADA is the sum of treatment-induced ADAs and treatment enhanced ADAs. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=36 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=38 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arms A and C (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin Baseline Prevalence of ADAs	0 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—
Arms A and C (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin Post-Baseline Incidence of ADAs	2.9 percentage of participants	—	7.9 percentage of participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline to approximately Month 24

Population: Safety population consisted of all ITT participants from Arms E and F (Phase II) who received at least one dose of study medication. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=20 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab Baseline Prevalence of ADAs to Polatuzumab	0 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—
Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab Post-Baseline Incidence of ADAs to Polatuzumab	5.6 percentage of participants	—	5.3 percentage of participants	—	—	—	—	—	—	—
Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab Baseline Prevalence of ADAs to Obinutuzumab	0 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—
Arms E and F (Phase II): Percentage of Participants With Treatment Emergent ADAs to Polatuzumab Vedotin and Obinutuzumab Post-Baseline Incidence of ADAs to Obinutuzumab	0 percentage of participants	—	0 percentage of participants	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

Population: ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.

CR was assessed by investigator at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator	63.4 percentage of participants Interval 46.94 to 77.88	42.5 percentage of participants Interval 27.04 to 59.11	64.1 percentage of participants Interval 47.18 to 78.8	15.0 percentage of participants Interval 5.71 to 29.84	65.0 percentage of participants Interval 40.78 to 84.61	33.3 percentage of participants Interval 14.59 to 56.97	36.8 percentage of participants Interval 27.63 to 46.71	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

Population: ITT population included all randomized participants in Phase II Expansion Cohorts and Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=42 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=20 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II Expansion Cohorts and Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC	33.3 percentage of participants Interval 14.59 to 56.97	35.7 percentage of participants Interval 21.55 to 51.97	65.0 percentage of participants Interval 40.78 to 84.61	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

Population: ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator according to MLRC. Per MLRC, CR based on PET-CT complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow, normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With Objective Response (OR) at PRA Based on PET-CT as Determined by Investigator	80.5 percentage of participants Interval 63.13 to 91.18	47.5 percentage of participants Interval 31.51 to 63.87	79.5 percentage of participants Interval 63.54 to 90.7	17.5 percentage of participants Interval 7.34 to 32.78	85.0 percentage of participants Interval 62.11 to 96.79	33.3 percentage of participants Interval 14.59 to 56.97	42.5 percentage of participants Interval 32.91 to 52.43	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of FDG-avid disease in bone marrow. Bone marrow normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC	73.2 percentage of participants Interval 57.06 to 85.78	42.5 percentage of participants Interval 27.04 to 59.11	76.9 percentage of participants Interval 60.67 to 88.87	17.5 percentage of participants Interval 7.34 to 32.78	85.0 percentage of participants Interval 62.11 to 96.79	38.1 percentage of participants Interval 18.11 to 61.56	43.4 percentage of participants Interval 33.8 to 53.37	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

Population: ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.

CR was determined by investigator at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 centimetres (cm) in in longest transverse diameter (LDi) and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts). As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator	19.5 percentage of participants Interval 8.82 to 34.87	20.0 percentage of participants Interval 9.05 to 35.65	46.2 percentage of participants Interval 30.09 to 62.82	5.0 percentage of participants Interval 0.61 to 16.92	20.0 percentage of participants Interval 5.73 to 43.66	14.3 percentage of participants Interval 3.05 to 36.34	14.2 percentage of participants Interval 8.14 to 22.26	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

Population: ITT population included all randomized participants in Phase II irrespective of whether or not they received the study treatment.

CR was determined by IRC a at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts). As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=20 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC	36.6 percentage of participants Interval 22.12 to 53.06	22.5 percentage of participants Interval 10.84 to 38.45	41.0 percentage of participants Interval 25.57 to 57.9	2.5 percentage of participants Interval 0.06 to 13.16	50.0 percentage of participants Interval 27.2 to 72.8	23.8 percentage of participants Interval 8.22 to 47.17	17.9 percentage of participants Interval 11.15 to 26.57	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in sum of the products of greatest diameters (SPD) of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by Investigator	75.6 percentage of participants Interval 59.7 to 87.64	45.0 percentage of participants Interval 29.26 to 61.51	79.5 percentage of participants Interval 63.54 to 90.7	15.0 percentage of participants Interval 5.71 to 29.84	80.0 percentage of participants Interval 56.34 to 94.27	33.3 percentage of participants Interval 14.59 to 56.97	42.5 percentage of participants Interval 32.91 to 52.43	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts) or last dose of study drug (up to approximately 28 weeks)

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; bone marrow normal by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts and 28 days for FL cohorts).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC	80.5 percentage of participants Interval 65.13 to 91.18	40.0 percentage of participants Interval 24.86 to 56.67	74.4 percentage of participants Interval 57.87 to 86.96	15.0 percentage of participants Interval 5.71 to 29.84	80.0 percentage of participants Interval 56.34 to 94.27	38.1 percentage of participants Interval 18.11 to 61.56	41.5 percentage of participants Interval 32.02 to 51.49	—	—	—

SECONDARY outcome

Timeframe: Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)

BOR=CR/PR per PET-CT/CT per MLRC.CR per PET-CT=complete MR in LN \& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no uptake(UT) above background;2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT markedly higher than liver \&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in LN \& ELS, score=4 or 5, reduced UT than baseline (BL) \& residual mass of any size;residual UT\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=41 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=39 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=20 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=21 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Percentage of Participants With Best Objective Response (BOR) Based on PET-CT or CT Only as Determined by the Investigator	90.2 percentage of participants Interval 76.87 to 97.28	70.0 percentage of participants Interval 53.47 to 83.44	89.7 percentage of participants Interval 75.78 to 97.13	32.5 percentage of participants Interval 18.57 to 49.13	90.0 percentage of participants Interval 68.3 to 98.77	52.4 percentage of participants Interval 29.78 to 74.29	62.3 percentage of participants Interval 52.33 to 71.5	—	—	—

SECONDARY outcome

Timeframe: Up to every 6 months until disease progression, withdrawal or study completion (up to approximately 84 months)

Population: ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=21 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
DLBCL Cohorts: Percentage of Participants With BOR Based PET-CT or CT Only as Determined by IRC	25.0 percentage of participants Interval 12.69 to 41.2	42.9 percentage of participants Interval 21.82 to 65.98	62.5 percentage of participants Interval 45.8 to 77.27	57.5 percentage of participants Interval 47.57 to 67.09	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)

Population: ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.

DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per investigator per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\> background; 2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT\>than liver \&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \& residual mass of any size at interim for LN \& ELS;residual UT\>UT in normal bone marrow but\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=13 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=11 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=28 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=66 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
DLBCL Cohorts: Duration of Response (DOR) Based on PET-CT or CT Only as Determined by the Investigator	4.074 months Interval 2.563 to 12.682	16.099 months Interval 2.825 to 27.86	12.665 months Interval 5.782 to 27.926	11.335 months Interval 6.242 to 16.197	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (up to approximately 84 months)

Population: ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.

DOR=first occurrence of CR/PR to disease progression/relapse/death per PET-CT/CT, per IRC per MLRC.CR per PET-CT=score 1/2/3 with/without a residual mass on 5-PS for LN and ELS;1=no UT\> background; 2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT\>than liver \&/or new lesions;bone marrow morphology=no evidence of FDG-avid disease, normal;if indeterminate IHC negative.PR per PET-CT=score of 4/5 with reduced UT compared to BL \& residual mass of any size at interim for LN \& ELS;residual UT\>UT in normal bone marrow but\<than BL. CR per CT=target nodes/nodal masses regressed to ≤1.5cm in LDi no ELS of disease for LN \& ELS, no non-measured lesion, organ enlargement regressed to normal; bone marrow=normal morphology; if indeterminate, IHC negative. PR per CT= ≥50% decrease SPD of 6 target measurable LN and extranodal sites, absent/normal/regressed but no increase in non-measured lesions, spleen ≥50% in length beyond normal involvement, no new sites of lesions.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=10 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=9 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=25 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=61 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
DLBCL Cohorts: DOR Based on PET-CT or CT Only as Determined by the IRC	10.645 months Interval 3.975 to 19.647	25.758 months Interval 9.692 to 46.752	10.908 months Interval 5.684 to 40.674	13.437 months Interval 8.641 to 20.041	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)

Population: ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment.

PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=21 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
DLBCL Cohorts: Progression Free Survival (PFS) Based on PET-CT or CT Only as Determined by the Investigator	2.037 months Interval 1.544 to 3.713	5.125 months Interval 2.103 to 18.234	7.491 months Interval 4.928 to 16.953	5.881 months Interval 4.764 to 7.524	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (up to approximately 84 months)

Population: ITT population included all randomized participants in DLBCL Cohorts irrespective of whether or not they received the study treatment.

PFS was defined as the time randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=40 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=21 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=40 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=106 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
DLBCL Cohorts: PFS Based on PET-CT or CT Only as Determined by the IRC	3.713 months Interval 2.07 to 4.534	5.848 months Interval 2.103 to 11.893	9.248 months Interval 6.045 to 13.93	6.965 months Interval 5.092 to 9.823	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

Population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

CR was assessed by Investigator at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohort: Percentage of Participants With CR at PRA Based on PET-CT as Determined by the Investigator	—	—	36.8 percentage of participants Interval 27.63 to 46.71	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

Population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. Values have been rounded off to the nearest whole number.

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately\>liver; 5=uptake markedly higher than liver and/or new lesions ; no new lesions and no evidence of FDG-avid disease in bone marrow, normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by Investigator	—	—	42.5 percentage of participants Interval 32.91 to 52.43	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC according to MLRC. Per MLRC, CR based on PET-CT= complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass on 5PS, where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions ; no new lesions and no evidence of FDG-avid disease in bone marrow, bone marrow normal by morphology; if indeterminate, IHC negative. PR based on PET-CT was defined as partial MR in lymph nodes and ELS with a score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size at interim, residual uptake higher than uptake in normal bone marrow but reduced compared with baseline (diffuse uptake compatible with reactive changes from chemotherapy allowed).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohort: Percentage of Participants With OR at PRA Based on PET-CT as Determined by IRC	—	—	43.4 percentage of participants Interval 33.8 to 53.37	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months])

BOR=CR/PR per PET-CT/CT per MLRC. CR per PET-CT=complete MR in lymph nodes \& ELS, score=1, 2,3 with/without a residual mass on 5-PS; 1=no UT above background; 2=UT≤mediastinum;3=UT\>mediastinum but ≤liver;4=UT moderately\>liver;5=UT markedly higher than liver \&/or new lesions;no evidence of FDG-avid disease, bone marrow morphology=normal;if indeterminate, is IHC negative.PR per PET-CT=partial MR in lymph nodes \& ELS, score=4 or 5, reduced UT than BL \& residual mass of any size;residual UT\>UT in normal marrow but reduced than BL.CR per CT=complete radiologic response with target nodes/nodal masses regressed to ≤1.5cm in LDi \& no ELS of disease, absences of non-measured lesion;organ enlargement regressed to normal;no new lesions;bone marrow= normal;if indeterminate, is IHC negative.PR per CT=≥50% decrease in SPD of up to 6 target nodes \& extranodal sites;non-measured lesions=absent/normal/regressed/no increase;spleen=regressed by ≥50% in length beyond normal, no new lesions.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the Investigator	—	—	62.3 percentage of participants Interval 52.33 to 71.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to every 6 months until disease progression, withdrawal or study completion (from Month 37 to Month 84 [up to approximately 47 months])

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohorts: Percentage of Participants With BOR Based on PET-CT or CT Only as Determined by the IRC	—	—	57.5 percentage of participants Interval 47.57 to 67.09	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of the first occurrence of a documented CR or PR to the date of disease progression, relapse, or death from any cause whichever occur first (from Month 37 to Month 84 [up to approximately 47 months])

Population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=66 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the Investigator	—	—	11.335 months Interval 6.242 to 16.197	—	—	—	—	—	—	—

SECONDARY outcome

Population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment. As pre-specified in the protocol data reported is combined for Arms G and H. 'Overall Number Analyzed' are the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=61 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohort: DOR Based on PET-CT or CT Only as Determined by the IRC	—	—	13.437 months Interval 8.641 to 20.041	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])

Population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the investigators assessment. As pre-specified in the protocol data reported is combined for Arms G and H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the Investigator	—	—	5.881 months Interval 4.764 to 7.524	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From the date of randomization or first treatment to the first occurrence of progression or relapse, or death from any cause (from Month 37 to Month 84 [up to approximately 47 months])

Population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

PFS was defined as the time from randomization or from first study treatment (for obinuzumab arms) to the first occurrence of disease progression, relapse or death, from any cause based on PET-CT or CT only, as determined by the IRC assessment. As pre-specified in the protocol data reported is combined for Arms G and H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohort: PFS Based on PET-CT or CT Only as Determined by the IRC	—	—	6.965 months Interval 5.092 to 9.823	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Month 37 to Month 84 (up to approximately 47 months)

Population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

EFS was defined as time from randomization to disease progression or relapse, as assessed by the investigator or death from any cause. As pre-specified in the protocol data reported is combined for Arms G and H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohort: Event-Free Survival (EFS) Based on PET-CT or CT Only, as Determined by the Investigator	—	—	5.092 months Interval 4.402 to 6.867	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From Month 37 to Month 84 (up to approximately 47 months)

Population: ITT population included all randomized participants in Phase II NF Cohort irrespective of whether or not they received the study treatment.

OS was defined as the time from the date of randomization or first treatment (for obinutuzumab arms) to the date of death from any cause. As pre-specified in the protocol data reported is combined for Arms G and H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=106 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II NF Cohorts: Overall Survival (OS)	—	—	12.320 months Interval 8.279 to 16.986	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

Population: ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

CR was assessed by IRC at PRA according to MLRC. Per MLRC, CR based on PET-CT was defined as complete MR in lymph nodes and ELS with a score of 1, 2, or 3 with or without residual mass, on 5PS where 1=no uptake above background; 2=uptake ≤ mediastinum; 3=uptake \> mediastinum but ≤ liver; 4=uptake moderately \> liver; 5=uptake markedly higher than liver and/or new lesions no evidence of FDG-avid disease in bone marrow. Bone marrow is normal by morphology; if indeterminate, IHC negative. As pre-specified in the protocol data reported is combined for Arms G and H. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts) or after final dose of study treatment. Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=42 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on PET-CT as Determined by the IRC	—	—	35.7 percentage of participants Interval 21.55 to 51.97	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

Population: ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

CR was determined by Investigator at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts). Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=42 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on CT Only as Determined by Investigator	—	—	9.5 percentage of participants Interval 2.66 to 22.62	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to approximately 23 weeks)

Population: ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment.

CR was determined by IRC at PRA according to the MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts). Values have been rounded off to the nearest whole number.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=42 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G (Phase II NF Cohort): Percentage of Participants With CR at PRA Based on CT Only as Determined by IRC	—	—	14.3 percentage of participants Interval 5.43 to 28.54	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to 23 weeks)

Population: ITT population included all randomized participants in Arm G (Phase II NF Cohort) irrespective of whether or not they received the study treatment. Values have been rounded off to the nearest whole number.

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the investigator based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=42 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G (Phase II NF Cohort): Percentage of Participants With OR at PRA Based on CT Only as Determined by Investigator	—	—	38.1 percentage of participants Interval 23.57 to 54.36	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 6 to 8 weeks after Cycle 6 Day 1 (cycle length is 21 days for DLBCL cohorts) or last dose of study drug (up to 23 weeks)

OR at PRA was defined as the percentage of participants with CR or PR at the PRA, as assessed by the IRC based on MLRC. Per MLRC, CR based on CT was defined as complete radiologic response in lymph nodes and ELS with target nodes/nodal masses regressing to ≤ 1.5 cm in LDi and no ELS of disease organ enlargement regressing to normal; no new lesions; normal bone marrow by morphology, if indeterminate, IHC negative. PR per CT only was defined as partial remission in lymph nodes and ELS with ≥50% decrease in SPD of up to 6 target measurable lymph nodes and extranodal sites, absent/normal/regressed but with no increase in non-measured lesions, spleen regressing by ≥50% in length beyond normal it, no new sites of lesions. The analysis was done 6-8 weeks after Cycle 6, Day 1 (each cycle is 21 days for DLBCL cohorts).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=42 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G (Phase II NF Cohort): Percentage of Participants With OR at PRA Based on CT Only as Determined by IRC	—	—	33.3 percentage of participants Interval 19.57 to 49.55	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2: pre-dose and 30 minutes (min) post dose; Cycle 1 Days 8 and 15; Cycle 2 and 4 Day 1: pre-dose and 30 min post dose; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)

Population: PK evaluable population included all the ITT participants in Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

PK of pola-related analyte acMMAE was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=36 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=36 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=18 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=19 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Study Treatment Completion	—	18.7 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	10.7 ng/mL Geometric Coefficient of Variation 181.7	14.2 ng/mL Geometric Coefficient of Variation 95.7	14.9 ng/mL Geometric Coefficient of Variation 69.4	12.3 ng/mL Geometric Coefficient of Variation 109.4	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 1 Day 2: Pre-dose	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were below lower limit of quantification (BLLQ).	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 1 Day 2: 30 min Post Dose	617 ng/mL Geometric Coefficient of Variation 26.2	719 ng/mL Geometric Coefficient of Variation 26.7	654 ng/mL Geometric Coefficient of Variation 29.3	718 ng/mL Geometric Coefficient of Variation 14.2	492 ng/mL Geometric Coefficient of Variation 241.6	643 ng/mL Geometric Coefficient of Variation 24.7	453 ng/mL Geometric Coefficient of Variation 682.8	472 ng/mL Geometric Coefficient of Variation 617.2	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 1 Day 8	75.9 ng/mL Geometric Coefficient of Variation 40.8	90.7 ng/mL Geometric Coefficient of Variation 46.1	29.4 ng/mL Geometric Coefficient of Variation 5887.2	109 ng/mL Geometric Coefficient of Variation 48.2	—	—	—	—	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 1 Day 15	25.4 ng/mL Geometric Coefficient of Variation 29.8	28.9 ng/mL Geometric Coefficient of Variation 48.6	12.2 ng/mL Geometric Coefficient of Variation 1626.9	34.4 ng/mL Geometric Coefficient of Variation 37.3	—	—	—	—	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 2 Day 1: Pre-dose	12.4 ng/mL Geometric Coefficient of Variation 47.9	8.75 ng/mL Geometric Coefficient of Variation 77.7	3.21 ng/mL Geometric Coefficient of Variation 546.5	16.6 ng/mL Geometric Coefficient of Variation 25.6	4.72 ng/mL Geometric Coefficient of Variation 159.8	12.7 ng/mL Geometric Coefficient of Variation 120.5	9.05 ng/mL Geometric Coefficient of Variation 74.4	13.1 ng/mL Geometric Coefficient of Variation 45.2	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 2 Day 1: 30 min Post Dose	683 ng/mL Geometric Coefficient of Variation 20.1	803 ng/mL Geometric Coefficient of Variation 20.1	685 ng/mL Geometric Coefficient of Variation 22.0	834 ng/mL Geometric Coefficient of Variation 13.5	—	—	—	—	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 4 Day 1: Pre-dose	21.1 ng/mL Geometric Coefficient of Variation 46.7	15.3 ng/mL Geometric Coefficient of Variation 61.9	12.2 ng/mL Geometric Coefficient of Variation 26.1	26.2 ng/mL Geometric Coefficient of Variation 22.1	11.2 ng/mL Geometric Coefficient of Variation 109.3	20.7 ng/mL Geometric Coefficient of Variation 46.4	15.2 ng/mL Geometric Coefficient of Variation 30.5	19.6 ng/mL Geometric Coefficient of Variation 30.5	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 4 Day 1: 30 min Post Dose	754 ng/mL Geometric Coefficient of Variation 14.4	734 ng/mL Geometric Coefficient of Variation 22.0	748 ng/mL Geometric Coefficient of Variation 23.4	716 ng/mL Geometric Coefficient of Variation 13.7	689 ng/mL Geometric Coefficient of Variation 20.9	645 ng/mL Geometric Coefficient of Variation 21.4	829 ng/mL Geometric Coefficient of Variation 20.3	709 ng/mL Geometric Coefficient of Variation 10.1	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Unscheduled Visit	—	—	—	—	—	41.1 ng/mL Geometric Coefficient of Variation 49.4	53.0 ng/mL Geometric Coefficient of Variation 58.0	—	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Unscheduled Visit: Pre-dose	—	—	—	—	1.21 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—
Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Unscheduled Visit: 30 min Post Dose	—	—	—	—	—	915 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose

Population: PK evaluable population included all the ITT participants in Arm G+H (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

PK of one pola-related analytes: acMMAE was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=102 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G+H (Phase II NF Cohorts): Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 1 Day 2: Post Dose	—	—	653 ng/mL Standard Deviation 237	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 2 Day 1: Pre-dose	—	—	14.6 ng/mL Standard Deviation 8.66	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 2 Day 1: Post Dose	—	—	667 ng/mL Standard Deviation 155	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 4 Day 1: Pre-dose	—	—	23.2 ng/mL Standard Deviation 8.59	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of of Polatuzumab Vedotin Analyte: acMMAE Cycle 4 Day 1: Post Dose	—	—	659 ng/mL Standard Deviation 156	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Days 2: pre-dose & 30 min post dose; Cycle 1 Days 8 & 15; Cycle 2 and 4 Day 1 and unscheduled visits: pre-dose & 30 min post dose; Follow up at Day 1: Months 3, 6, 12, 18 & 24; study treatment completion visit (up to approx. 84 months)

Population: PK evaluable population included all the ITT participants Phase Ib and Phase II who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

PK of pola-related analyte Total Ab was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=36 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=36 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=18 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=19 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Cycle 1 Day 2: Pre-dose	NA grams per milliliters (g/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA grams per milliliters (g/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA grams per milliliters (g/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA grams per milliliters (g/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA grams per milliliters (g/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA grams per milliliters (g/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA grams per milliliters (g/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA grams per milliliters (g/mL) Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Cycle 1 Day 2: 30 min Post Dose	36.6 grams per milliliters (g/mL) Geometric Coefficient of Variation 25.4	37.5 grams per milliliters (g/mL) Geometric Coefficient of Variation 29.1	33.2 grams per milliliters (g/mL) Geometric Coefficient of Variation 28.4	34.3 grams per milliliters (g/mL) Geometric Coefficient of Variation 20.3	35.4 grams per milliliters (g/mL) Geometric Coefficient of Variation 27.7	34.6 grams per milliliters (g/mL) Geometric Coefficient of Variation 26.2	32.4 grams per milliliters (g/mL) Geometric Coefficient of Variation 22.8	38.3 grams per milliliters (g/mL) Geometric Coefficient of Variation 20.3	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Cycle 1 Day 8	9.01 grams per milliliters (g/mL) Geometric Coefficient of Variation 43.7	10.2 grams per milliliters (g/mL) Geometric Coefficient of Variation 39.3	3.43 grams per milliliters (g/mL) Geometric Coefficient of Variation 4393.4	10.0 grams per milliliters (g/mL) Geometric Coefficient of Variation 31.9	—	—	—	—	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Cycle 1 Day 15	4.26 grams per milliliters (g/mL) Geometric Coefficient of Variation 35.3	4.61 grams per milliliters (g/mL) Geometric Coefficient of Variation 40.6	1.83 grams per milliliters (g/mL) Geometric Coefficient of Variation 1784.3	5.22 grams per milliliters (g/mL) Geometric Coefficient of Variation 28.4	—	—	—	—	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Cycle 2 Day 1: Pre-dose	2.31 grams per milliliters (g/mL) Geometric Coefficient of Variation 54.2	2.20 grams per milliliters (g/mL) Geometric Coefficient of Variation 76.1	0.696 grams per milliliters (g/mL) Geometric Coefficient of Variation 941.2	3.70 grams per milliliters (g/mL) Geometric Coefficient of Variation 27.4	1.23 grams per milliliters (g/mL) Geometric Coefficient of Variation 203.1	2.48 grams per milliliters (g/mL) Geometric Coefficient of Variation 137.6	2.20 grams per milliliters (g/mL) Geometric Coefficient of Variation 100.6	2.83 grams per milliliters (g/mL) Geometric Coefficient of Variation 41.8	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Cycle 2 Day 1: 30 min Post Dose	39.5 grams per milliliters (g/mL) Geometric Coefficient of Variation 28.3	43.4 grams per milliliters (g/mL) Geometric Coefficient of Variation 31.1	35.8 grams per milliliters (g/mL) Geometric Coefficient of Variation 25.9	42.2 grams per milliliters (g/mL) Geometric Coefficient of Variation 22.9	—	—	—	—	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Cycle 4 Day 1: Pre-dose	5.03 grams per milliliters (g/mL) Geometric Coefficient of Variation 59.0	4.61 grams per milliliters (g/mL) Geometric Coefficient of Variation 62.2	3.44 grams per milliliters (g/mL) Geometric Coefficient of Variation 30.5	6.26 grams per milliliters (g/mL) Geometric Coefficient of Variation 18.3	3.61 grams per milliliters (g/mL) Geometric Coefficient of Variation 97.8	5.72 grams per milliliters (g/mL) Geometric Coefficient of Variation 39.9	4.82 grams per milliliters (g/mL) Geometric Coefficient of Variation 20.8	5.03 grams per milliliters (g/mL) Geometric Coefficient of Variation 29.3	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Cycle 4 Day 1: 30 min Post Dose	44.6 grams per milliliters (g/mL) Geometric Coefficient of Variation 11.0	43.0 grams per milliliters (g/mL) Geometric Coefficient of Variation 25.8	40.2 grams per milliliters (g/mL) Geometric Coefficient of Variation 27.2	47.1 grams per milliliters (g/mL) Geometric Coefficient of Variation 24.2	44.8 grams per milliliters (g/mL) Geometric Coefficient of Variation 24.3	40.6 grams per milliliters (g/mL) Geometric Coefficient of Variation 20.6	55.0 grams per milliliters (g/mL) Geometric Coefficient of Variation 21.3	37.5 grams per milliliters (g/mL) Geometric Coefficient of Variation 11.6	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Follow up on Month 3, Day 1	0.771 grams per milliliters (g/mL) Geometric Coefficient of Variation 193.4	0.910 grams per milliliters (g/mL) Geometric Coefficient of Variation 82.8	0.164 grams per milliliters (g/mL) Geometric Coefficient of Variation 51.9	0.394 grams per milliliters (g/mL) Geometric Coefficient of Variation 27.1	0.265 grams per milliliters (g/mL) Geometric Coefficient of Variation 209.9	0.316 grams per milliliters (g/mL) Geometric Coefficient of Variation 266.2	0.489 grams per milliliters (g/mL) Geometric Coefficient of Variation 174.2	0.543 grams per milliliters (g/mL) Geometric Coefficient of Variation 126.7	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Follow up on Month 6, Day 1	0.0788 grams per milliliters (g/mL) Geometric Coefficient of Variation 230.0	0.219 grams per milliliters (g/mL) Geometric Coefficient of Variation 96.6	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.104 grams per milliliters (g/mL) Geometric Coefficient of Variation 18.5	0.0539 grams per milliliters (g/mL) Geometric Coefficient of Variation 145.7	0.0564 grams per milliliters (g/mL) Geometric Coefficient of Variation 195.7	0.0920 grams per milliliters (g/mL) Geometric Coefficient of Variation 123.5	0.150 grams per milliliters (g/mL) Geometric Coefficient of Variation 206.6	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Follow up on Month 12, Day 1	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0298 grams per milliliters (g/mL) Geometric Coefficient of Variation 35.9	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0301 grams per milliliters (g/mL) Geometric Coefficient of Variation 60.6	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Follow up on Month 18, Day 1	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	—	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Follow up on Month 24, Day 1	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated..	—	—	—	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Unscheduled Visit	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	—	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation 0.0	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	1.65 grams per milliliters (g/mL) Geometric Coefficient of Variation 5419.8	1.23 grams per milliliters (g/mL) Geometric Coefficient of Variation 30267.8	—	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Unscheduled Visit: Pre-dose	—	—	—	—	0.279 grams per milliliters (g/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0250 grams per milliliters (g/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Unscheduled Visit: 30 min Post Dose	—	—	—	—	—	42.0 grams per milliliters (g/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—
Serum Concentration of of Polatuzumab Vedotin Analyte: Total Ab Study Treatment Completion Visit	—	5.34 grams per milliliters (g/mL) Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	3.34 grams per milliliters (g/mL) Geometric Coefficient of Variation 180.5	4.33 grams per milliliters (g/mL) Geometric Coefficient of Variation 69.4	4.57 grams per milliliters (g/mL) Geometric Coefficient of Variation 57.2	3.23 grams per milliliters (g/mL) Geometric Coefficient of Variation 79.3	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2: post dose; Cycle 2 and 4 Day 1: pre-dose and post dose

PK of pola-related analyte: Total Ab was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=103 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab Cycle 1 Day 2: Post Dose	—	—	33.9 ng/mL Standard Deviation 11.7	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab Cycle 2 Day 1: Pre-dose	—	—	3.27 ng/mL Standard Deviation 4.37	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab Cycle 2 Day 1: Post Dose	—	—	36.0 ng/mL Standard Deviation 8.71	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab Cycle 4 Day 1: Pre-dose	—	—	5.41 ng/mL Standard Deviation 1.79	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Total Ab Cycle 4 Day 1: Post Dose	—	—	39.2 ng/mL Standard Deviation 7.30	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2: pre-dose and 30 min post dose, Cycle 1 Days 8 and 15; Cycles 2 and 4: pre-dose and 30 min post dose; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)

PK of pola-related analytes unconjugated MMAE was measured. Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=36 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=36 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=18 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=18 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 1 Day 2: Pre-dose	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 1 Day 2: 30 min Post Dose	0.234 ng/mL Geometric Coefficient of Variation 80.2	0.397 ng/mL Geometric Coefficient of Variation 67.7	0.726 ng/mL Geometric Coefficient of Variation 297.5	0.327 ng/mL Geometric Coefficient of Variation 41.4	0.402 ng/mL Geometric Coefficient of Variation 80.2	0.315 ng/mL Geometric Coefficient of Variation 105.3	0.243 ng/mL Geometric Coefficient of Variation 101.8	0.456 ng/mL Geometric Coefficient of Variation 103.1	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 1 Day 8	1.84 ng/mL Geometric Coefficient of Variation 78.4	1.96 ng/mL Geometric Coefficient of Variation 51.5	1.48 ng/mL Geometric Coefficient of Variation 100.8	2.34 ng/mL Geometric Coefficient of Variation 21.4	—	—	—	—	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 1 Day 15	0.531 ng/mL Geometric Coefficient of Variation 88.5	0.705 ng/mL Geometric Coefficient of Variation 60.0	0.311 ng/mL Geometric Coefficient of Variation 93.8	0.688 ng/mL Geometric Coefficient of Variation 19.5	—	—	—	—	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 2 Day 1: Pre-dose	0.158 ng/mL Geometric Coefficient of Variation 79.4	0.0512 ng/mL Geometric Coefficient of Variation 129.3	0.0264 ng/mL Geometric Coefficient of Variation 70.8	0.150 ng/mL Geometric Coefficient of Variation 44.4	0.0373 ng/mL Geometric Coefficient of Variation 81.5	0.159 ng/mL Geometric Coefficient of Variation 80.9	0.0451 ng/mL Geometric Coefficient of Variation 76.9	0.186 ng/mL Geometric Coefficient of Variation 86.8	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 2 Day 1: 30 min Post Dose	0.263 ng/mL Geometric Coefficient of Variation 72.7	0.231 ng/mL Geometric Coefficient of Variation 53.5	0.185 ng/mL Geometric Coefficient of Variation 54.2	0.345 ng/mL Geometric Coefficient of Variation 31.9	—	—	—	—	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 4 Day 1: Pre-dose	0.133 ng/mL Geometric Coefficient of Variation 72.6	0.0511 ng/mL Geometric Coefficient of Variation 68.3	0.0414 ng/mL Geometric Coefficient of Variation 102.9	0.150 ng/mL Geometric Coefficient of Variation 44.3	0.0554 ng/mL Geometric Coefficient of Variation 77.3	0.158 ng/mL Geometric Coefficient of Variation 58.2	0.0481 ng/mL Geometric Coefficient of Variation 83.2	0.141 ng/mL Geometric Coefficient of Variation 102.3	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 4 Day 1: 30 min Post Dose	0.266 ng/mL Geometric Coefficient of Variation 27.0	0.167 ng/mL Geometric Coefficient of Variation 39.2	0.234 ng/mL Geometric Coefficient of Variation 35.0	0.257 ng/mL Geometric Coefficient of Variation 32.3	0.198 ng/mL Geometric Coefficient of Variation 32.0	0.316 ng/mL Geometric Coefficient of Variation 38.9	0.195 ng/mL Geometric Coefficient of Variation 38.1	0.283 ng/mL Geometric Coefficient of Variation 56.9	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Unscheduled Visit	—	—	—	—	—	—	0.738 ng/mL Geometric Coefficient of Variation 64.6	—	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Unscheduled Visit: Pre-dose	—	—	—	—	0.0180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.0180 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Unscheduled Visit: 30 min Post Dose	—	—	—	—	—	0.114 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—
Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Study Treatment Completion	—	0.0595 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	0.0506 ng/mL Geometric Coefficient of Variation 113.0	0.0749 ng/mL Geometric Coefficient of Variation 165.9	0.0682 ng/mL Geometric Coefficient of Variation 110.4	0.150 ng/mL Geometric Coefficient of Variation 179.4	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2: post dose; Cycle 1 and 3 Day 8 and 15; Cycle 2, 3 and 4 Day 1: pre-dose and post dose

Population: PK evaluable population included all the ITT participants in Arm G (Phase II NF Cohort) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

PK of one pola-related analytes: Unconjugated MMAE was measured. Cycle length is 21 days for DLBCL cohorts. As pre-specified in the protocol data is reported combined for arms G+H.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=103 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 1 Day 2: Post Dose	—	—	0.590 ng/mL Standard Deviation 1.08	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 2 Day 1: Pre-dose	—	—	0.229 ng/mL Standard Deviation 0.248	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 2 Day 1: Post Dose	—	—	0.316 ng/mL Standard Deviation 0.213	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 4 Day 1: Pre-dose	—	—	0.186 ng/mL Standard Deviation 0.118	—	—	—	—	—	—	—
Arm G+H (Phase II NF Cohorts): Plasma Concentration of Polatuzumab Vedotin Analyte: Unconjugated MMAE Cycle 4 Day 1: Post Dose	—	—	0.256 ng/mL Standard Deviation 0.118	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2: pre-dose, 5 min, 1 hour (h); 2h, 3h and 4h post dose

Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol plasma concentration of bendamustine was not assessed in the Phase II NF Cohort (Arm G+H).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=37 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=39 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=35 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=33 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL n=18 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=19 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Plasma Concentration of Bendamustine Cycle 1 Day 2: Pre-dose	—	—	—	—	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.
Plasma Concentration of Bendamustine Cycle 1 Day 2: 5 min Post Dose	—	—	—	—	2130 ng/mL Geometric Coefficient of Variation 665.6	2810 ng/mL Geometric Coefficient of Variation 222.7	2740 ng/mL Geometric Coefficient of Variation 550.9	1700 ng/mL Geometric Coefficient of Variation 1865.5	3090 ng/mL Geometric Coefficient of Variation 68.3	3790 ng/mL Geometric Coefficient of Variation 119.4
Plasma Concentration of Bendamustine Cycle 1 Day 2: 1h Post Dose	—	—	—	—	456 ng/mL Geometric Coefficient of Variation 167.8	353 ng/mL Geometric Coefficient of Variation 187.9	518 ng/mL Geometric Coefficient of Variation 154.2	451 ng/mL Geometric Coefficient of Variation 380.2	478 ng/mL Geometric Coefficient of Variation 111.4	639 ng/mL Geometric Coefficient of Variation 165.6
Plasma Concentration of Bendamustine Cycle 1 Day 2: 2h Post Dose	—	—	—	—	84.4 ng/mL Geometric Coefficient of Variation 173.5	55.1 ng/mL Geometric Coefficient of Variation 236.5	93.8 ng/mL Geometric Coefficient of Variation 250.5	101 ng/mL Geometric Coefficient of Variation 375.8	62.8 ng/mL Geometric Coefficient of Variation 104.3	128 ng/mL Geometric Coefficient of Variation 196.7
Plasma Concentration of Bendamustine Cycle 1 Day 2: 3h Post Dose	—	—	—	—	20.5 ng/mL Geometric Coefficient of Variation 220.1	12.7 ng/mL Geometric Coefficient of Variation 246.4	23.5 ng/mL Geometric Coefficient of Variation 461.0	21.5 ng/mL Geometric Coefficient of Variation 509.9	12.4 ng/mL Geometric Coefficient of Variation 132.0	28.2 ng/mL Geometric Coefficient of Variation 287.4
Plasma Concentration of Bendamustine Cycle 1 Day 2: 4h Post Dose	—	—	—	—	7.60 ng/mL Geometric Coefficient of Variation 278.5	4.58 ng/mL Geometric Coefficient of Variation 268.4	8.11 ng/mL Geometric Coefficient of Variation 724.8	8.08 ng/mL Geometric Coefficient of Variation 615.9	3.30 ng/mL Geometric Coefficient of Variation 147.2	6.18 ng/mL Geometric Coefficient of Variation 131.0

SECONDARY outcome

Timeframe: Cycle 1 Days 1: pre-dose and 30 min post dose; Cycle 2 and 4 Day 1: pre-dose; unscheduled visits: pre-dose and 30 min post dose (up to approximately 84 months)

Population: PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) and Arms A-D (Phase II) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts. As pre specified in the protocol serum concentration of rituximab was not assessed in the Phase II NF Cohort (Arm G+H).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=37 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=38 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=34 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=34 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Serum Concentration of Rituximab Cycle 1 Days 1: Pre-dose	—	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	—	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA ng/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	—	—	—	—
Serum Concentration of Rituximab Cycle 1 Days 1: 30 min Post Dose	—	182 ng/mL Geometric Coefficient of Variation 27.2	—	202 ng/mL Geometric Coefficient of Variation 24.5	188 ng/mL Geometric Coefficient of Variation 19.9	180 ng/mL Geometric Coefficient of Variation 18.0	—	—	—	—
Serum Concentration of Rituximab Cycle 2 Days 1: Pre-dose	—	22.8 ng/mL Geometric Coefficient of Variation 79.2	—	20.2 ng/mL Geometric Coefficient of Variation 145.9	34.9 ng/mL Geometric Coefficient of Variation 89.9	34.6 ng/mL Geometric Coefficient of Variation 69.7	—	—	—	—
Serum Concentration of Rituximab Cycle 4 Days 1: Pre-dose	—	65.1 ng/mL Geometric Coefficient of Variation 46.5	—	62.3 ng/mL Geometric Coefficient of Variation 42.7	74.7 ng/mL Geometric Coefficient of Variation 50.9	83.3 ng/mL Geometric Coefficient of Variation 49.1	—	—	—	—
Serum Concentration of Rituximab Unscheduled: Pre-dose	—	30.6 ng/mL Geometric Coefficient of Variation 118.0	—	—	298 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	2.00 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—
Serum Concentration of Rituximab Unscheduled: 30 min Post Dose	—	—	—	—	—	165 ng/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1 and 4 Days 1: pre-dose and 30 min post dose; Cycle 2 Day1: pre-dose; Follow up visits on Day 1: Months 3, 6, 12, 18 and 24; unscheduled visits: pre-dose and 30 min post dose; study treatment completion (up to approximately 84 months)

Population: PK evaluable population included all the ITT participants who Cohort 1b (Phase 1b) and Arms E and F (Phase II) received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoint.

Cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=19 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=19 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Serum Concentration of Obinutuzumab Cycle 1 Day 1: Pre-dose	NA g/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA g/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA g/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	NA g/mL Geometric Coefficient of Variation NA The data is not evaluable as the samples were BLLQ.	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Cycle 1 Day 1: 30 min Post Dose	—	341 g/mL Geometric Coefficient of Variation 22.1	—	221 g/mL Geometric Coefficient of Variation 105.5	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Cycle 2 Day 1: Pre-dose	412 g/mL Geometric Coefficient of Variation 40.8	301 g/mL Geometric Coefficient of Variation 39.3	283 g/mL Geometric Coefficient of Variation 38.4	349 g/mL Geometric Coefficient of Variation 58.0	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Cycle 4 Day 1: Pre-dose	359 g/mL Geometric Coefficient of Variation 28.9	291 g/mL Geometric Coefficient of Variation 37.9	293 g/mL Geometric Coefficient of Variation 53.8	290 g/mL Geometric Coefficient of Variation 36.4	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Cycle 4 Day 1: 30 min Post Dose	—	701 g/mL Geometric Coefficient of Variation 27.4	—	642 g/mL Geometric Coefficient of Variation 29.5	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Follow up on Month 3, Day 1	28.8 g/mL Geometric Coefficient of Variation 17.0	38.5 g/mL Geometric Coefficient of Variation 167.8	67.7 g/mL Geometric Coefficient of Variation 47.8	55.1 g/mL Geometric Coefficient of Variation 119.9	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Follow up on Month 6, Day 1	5.38 g/mL Geometric Coefficient of Variation 12.4	7.64 g/mL Geometric Coefficient of Variation 412.2	11.5 g/mL Geometric Coefficient of Variation 56.6	15.8 g/mL Geometric Coefficient of Variation 137.6	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Follow up on Month 12, Day 1	0.389 g/mL Geometric Coefficient of Variation 119.3	0.162 g/mL Geometric Coefficient of Variation 569.7	0.237 g/mL Geometric Coefficient of Variation 717.6	0.732 g/mL Geometric Coefficient of Variation 18.7	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Follow up on Month 18, Day 1	0.0107 g/mL Geometric Coefficient of Variation 170.5	0.00842 g/mL Geometric Coefficient of Variation 347.4	0.00978 g/mL Geometric Coefficient of Variation 1188.5	0.0460 g/mL Geometric Coefficient of Variation 86.9	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Follow up on Month 24, Day 1	0.00203 g/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	0.00203 g/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	0.00203 g/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Unscheduled	3.09 g/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	20.8 g/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Unscheduled Visit: Pre-dose	—	—	—	0.0626 g/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Unscheduled Visit: 30 min Post Dose	—	—	—	349 g/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	—	—	—	—	—	—
Serum Concentration of Obinutuzumab Study Treatment Completion Visit	—	242 g/mL Geometric Coefficient of Variation 52.7	367 g/mL Geometric Coefficient of Variation NA Since only 1 participant was analyzed, the geometric coefficient of variation was not calculated.	232 g/mL Geometric Coefficient of Variation 46.2	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Cmax was not evaluated for Bendamustine and Rituximab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a Total Ab: Cycle 4	44.8 ng/mL Standard Deviation 5.06	—	41.3 ng/mL Standard Deviation 9.98	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a Unconjugated MMAE: Cycle 1	2.21 ng/mL Standard Deviation 1.34	—	3.31 ng/mL Standard Deviation 4.00	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a acMMAE: Cycle 1	634 ng/mL Standard Deviation 158	—	676 ng/mL Standard Deviation 176	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a acMMAE: Cycle 2	694 ng/mL Standard Deviation 138	—	697 ng/mL Standard Deviation 129	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a acMMAE: Cycle 4	759 ng/mL Standard Deviation 107	—	763 ng/mL Standard Deviation 159	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a Total Ab: Cycle 1	37.6 ng/mL Standard Deviation 9.42	—	34.3 ng/mL Standard Deviation 8.57	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a Total Ab: Cycle 2	40.6 ng/mL Standard Deviation 9.46	—	36.6 ng/mL Standard Deviation 8.00	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycles 1, 2 and 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Cmax was not evaluated for Bendamustine and Obinutuzumab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b acMMAE: Cycle 1	725 ng/mL Standard Deviation 104	—	738 ng/mL Standard Deviation 165	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b acMMAE: Cycle 2	841 ng/mL Standard Deviation 115	—	816 ng/mL Standard Deviation 168	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b acMMAE: Cycle 4	721 ng/mL Standard Deviation 97.7	—	749 ng/mL Standard Deviation 158	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b Total Ab: Cycle 1	34.9 ng/mL Standard Deviation 7.52	—	38.7 ng/mL Standard Deviation 9.84	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b Total Ab: Cycle 2	43.1 ng/mL Standard Deviation 9.52	—	45.0 ng/mL Standard Deviation 12.1	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b Total Ab: Cycle 4	48.2 ng/mL Standard Deviation 12.5	—	44.2 ng/mL Standard Deviation 11.2	—	—	—	—	—	—	—
Phase Ib: Cmax of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b Unconjugated MMAE: Cycle 1	2.39 ng/mL Standard Deviation 0.492	—	2.17 ng/mL Standard Deviation 1.08	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Arms A and C who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints.

PK of three pola-related analytes: acMMAE, total antibody and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=35 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=36 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C acMMAE: Cycle 1	661 ng/mL Standard Deviation 149	—	622 ng/mL Standard Deviation 194	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C acMMAE: Cycle 4	659 ng/mL Standard Deviation 135	—	703 ng/mL Standard Deviation 150	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C Total Ab: Cycle 1	35.7 ng/mL Standard Deviation 8.50	—	36.7 ng/mL Standard Deviation 9.54	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C Total Ab: Cycle 4	41.4 ng/mL Standard Deviation 8.29	—	46.1 ng/mL Standard Deviation 11.4	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C Bendamustine: Cycle 1	4.23 ng/mL Standard Deviation 2.26	—	3.57 ng/mL Standard Deviation 2.06	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C Rituximab: Cycle 1	191 ng/mL Standard Deviation 35.9	—	188 ng/mL Standard Deviation 49.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Arms B and D who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=33 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=38 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Cmax of Bendamustine and Rituximab in Arms B and D Bendamustine	3.85 ug/mL Standard Deviation 2.91	—	3.21 ug/mL Standard Deviation 2.09	—	—	—	—	—	—	—
Phase II: Cmax of Bendamustine and Rituximab in Arms B and D Rituximab	183 ug/mL Standard Deviation 33.6	—	207 ug/mL Standard Deviation 50.1	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1; Cycle 4 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints.

PK of three pola-related analytes: acMMAE, unconjugated MMAE and total antibody were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=19 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=18 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F acMMAE: Cycle 1	703 ug/mL Standard Deviation 211	—	692 ug/mL Standard Deviation 230	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F acMMAE: Cycle 4	713 ug/mL Standard Deviation 70.6	—	845 ug/mL Standard Deviation 165	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F Total Ab: Cycle 1	39.0 ug/mL Standard Deviation 7.63	—	33.3 ug/mL Standard Deviation 8.04	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F Total Ab: Cycle 4	37.8 ug/mL Standard Deviation 4.51	—	56.1 ug/mL Standard Deviation 11.2	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F Bendamustine: Cycle 1	5.47 ug/mL Standard Deviation 4.30	—	3.30 ug/mL Standard Deviation 1.58	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F Obinutuzumab: Cycle 1	274 ug/mL Standard Deviation 118	—	349 ug/mL Standard Deviation 72.8	—	—	—	—	—	—	—
Phase II: Cmax of Polatuzumab Vedotin, Obinutuzumab and Bendamustine in Arms E and F Obinutuzumab: Cycle 4	666 ug/mL Standard Deviation 190	—	727 ug/mL Standard Deviation 217	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4,(cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

Population: As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for bendamustine and rituximab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured. The unit of measure for AUC is day\*micrograms per milliliter \[day\*ug/mL\]).

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=4 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: AUC From Time Zero to Infinity (AUCinf) of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a acMMAE	2110 day*ug/mL Geometric Coefficient of Variation 28.4	—	2830 day*ug/mL Geometric Coefficient of Variation 12.1	—	—	—	—	—	—	—
Phase Ib: AUC From Time Zero to Infinity (AUCinf) of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a Total Ab	214 day*ug/mL Geometric Coefficient of Variation 35.9	—	298 day*ug/mL Geometric Coefficient of Variation 4.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema AUC was not evaluated for bendamustine and obinutuzumab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b acMMAE	2650 day*ug/mL Geometric Coefficient of Variation 16.4	—	2600 day*ug/mL Geometric Coefficient of Variation 34.4	—	—	—	—	—	—	—
Phase Ib: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b Total Ab	252 day*ug/mL Geometric Coefficient of Variation 21.6	—	267 day*ug/mL Geometric Coefficient of Variation 30.2	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=30 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=31 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Rituximab in Arms A and C Bendamustine	3.62 h*ug/mL Geometric Coefficient of Variation 78.5	—	3.29 h*ug/mL Geometric Coefficient of Variation 73.3	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=29 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=33 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: AUCinf of Bendamustine and Rituximab in Arms B and D Bendamustine	3.43 h*ug/mL Geometric Coefficient of Variation 97.4	—	2.86 h*ug/mL Geometric Coefficient of Variation 67.3	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=14 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=15 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: AUCinf of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Arms E and F Bendamustine	4.10 h*ug/mL Geometric Coefficient of Variation 67.4	—	2.88 h*ug/mL Geometric Coefficient of Variation 28.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (each cycle is 21 days DLBCL cohorts) up to approximately 9 weeks

Population: As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

PK of three pola-related analytes: antibody acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for bendamustine and rituximab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=4 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a acMMAE	15.2 mL/day/kg Geometric Coefficient of Variation 27.9	—	11.3 mL/day/kg Geometric Coefficient of Variation 12.9	—	—	—	—	—	—	—
Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Rituximab in Cohort 1a Total Ab	8.48 mL/day/kg Geometric Coefficient of Variation 35.2	—	6.05 mL/day/kg Geometric Coefficient of Variation 4.7	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for bendamustine and obinutuzumab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b acMMAE	12.1 mL/day/kg Geometric Coefficient of Variation 17.0	—	12.3 mL/day/kg Geometric Coefficient of Variation 34.9	—	—	—	—	—	—	—
Phase Ib: CL of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b Total Ab	7.17 mL/day/kg Geometric Coefficient of Variation 22.2	—	6.76 mL/day/kg Geometric Coefficient of Variation 30.6	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Arms A and B who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema CL was not evaluated for pola and rituximab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=29 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=30 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: CL of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C Bendamustine	42.6 Liters per hour (L/h) Geometric Coefficient of Variation 66.4	—	47.9 Liters per hour (L/h) Geometric Coefficient of Variation 60.8	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=29 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=32 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: CL of Bendamustine and Rituximab in Arms B and D Bendamustine	46.4 L/h Geometric Coefficient of Variation 93.9	—	54.4 L/h Geometric Coefficient of Variation 60.9	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=14 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=15 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: CL of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F Bendamustine	39.9 L/h Geometric Coefficient of Variation 76.1	—	61.3 L/h Geometric Coefficient of Variation 33.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

Population: As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Cohort 1a (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and rituximab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=4 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1a acMMAE	82.7 mL/kg Geometric Coefficient of Variation 33.2	—	73.0 mL/kg Geometric Coefficient of Variation 22.3	—	—	—	—	—	—	—
Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1a Total Ab	76.6 mL/kg Geometric Coefficient of Variation 25.7	—	82.3 mL/kg Geometric Coefficient of Variation 9.1	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Population: PK evaluable population included all the ITT participants in Cohort 1b (Phase Ib) who received at least one study treatment and who provided suitable PK samples. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for bendamustine and obinutuzumab.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b acMMAE	64.7 mL/kg Standard Deviation 23.0	—	77.2 mL/kg Standard Deviation 38.8	—	—	—	—	—	—	—
Phase Ib: Vss of Polatuzumab Vedotin, Bendamustine, and Obinutuzumab in Cohort 1b Total Ab	87.9 mL/kg Standard Deviation 24.7	—	87.5 mL/kg Standard Deviation 38.5	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=29 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=29 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Rituximab in Arms A and C Bendamustine	34.3 L Geometric Coefficient of Variation 57.7	—	36.5 L Geometric Coefficient of Variation 86.4	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=24 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=31 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Vss of Bendamustine and Rituximab in Arms B and D Bendamustine	33.2 L Geometric Coefficient of Variation 62.9	—	44.9 L Geometric Coefficient of Variation 69.6	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=12 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=14 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F Bendamustine	31.5 L Geometric Coefficient of Variation 68.1	—	51.2 L Geometric Coefficient of Variation 33.6	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks

Population: As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.

PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Every week during treatment (up to 24 weeks) and for the first 2 months after treatment, thereafter every month for 10 months or until withdrawal (up to 18 months overall)

Population: ITT population included all randomized participants in Arms A-F (Phase II) irrespective of whether or not they received the study treatment. 'Overall Number Analysed' =number of participants with data available for analysis. 'Number of Participants Analyzed'=number of participants evaluable for this outcome measure. Participants from Arm F did not answer a sufficient number of questions at both baseline and end of treatment visit therefore the average score could not be calculated.

The TINAS is an 11-item questionnaire that assesses the severity of neuropathy-related symptoms in the last 24 hours. The 11 items assessed were: hot/burning sensations in hands/feet, sensations pins and needles arms/legs, numbness or tingling in hands/feet, sensations of electric shock, pain when touching cold things, cramps in hands/feet, discomfort when touching things, discomfort skin contact with something, trouble grasping small objects, trouble walking loss feeling legs/feet, difficulty balance loss feeling leg/feet. Each item was scored on a 0-10 scale, with 0 being the symptom is not present, and 10 being the symptom is as bad as the participant can imagine. Higher scores indicate more severe disease. Scores were averaged at each week.

Outcome measures

Outcome measures
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=14 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=11 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=15 Participants Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=12 Participants Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=5 Participants Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm E (Phase II Expansion): Pola+BG in FL Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 4	0.8 Points on scale Standard Deviation 1.8	0.3 Points on scale Standard Deviation 0.3	0.1 Points on scale Standard Deviation 0.2	0.7 Points on scale Standard Deviation 0.8	0.2 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 8	0.8 Points on scale Standard Deviation 1.8	0.2 Points on scale Standard Deviation 0.5	0.3 Points on scale Standard Deviation 0.4	0.6 Points on scale Standard Deviation 0.9	0.2 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 10	0.4 Points on scale Standard Deviation 0.8	0.1 Points on scale Standard Deviation 0.1	0.5 Points on scale Standard Deviation 0.9	0.2 Points on scale Standard Deviation 0.4	0.1 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 11	0.5 Points on scale Standard Deviation 0.9	0.2 Points on scale Standard Deviation 0.2	0.5 Points on scale Standard Deviation 1.0	0.4 Points on scale Standard Deviation 0.6	0.1 Points on scale Standard Deviation 0.1	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 14	0.7 Points on scale Standard Deviation 1.8	0.3 Points on scale Standard Deviation 0.3	0.6 Points on scale Standard Deviation 1.2	0.4 Points on scale Standard Deviation 0.6	0.2 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 29	0.8 Points on scale Standard Deviation 2.1	0.7 Points on scale Standard Deviation 0.7	0.2 Points on scale Standard Deviation 0.2	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 30	0.7 Points on scale Standard Deviation 1.9	0.8 Points on scale Standard Deviation 0.8	0.7 Points on scale Standard Deviation 1.1	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation 0.1	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 31	0.0 Points on scale Standard Deviation 0.1	1.3 Points on scale Standard Deviation 0.9	0.3 Points on scale Standard Deviation 0.3	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation 0.1	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 32	0.1 Points on scale Standard Deviation 0.1	1.0 Points on scale Standard Deviation 0.9	0.4 Points on scale Standard Deviation 0.4	—	0.2 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 33	0.1 Points on scale Standard Deviation 0.2	1.0 Points on scale Standard Deviation 1.0	0.3 Points on scale Standard Deviation 0.3	—	0.2 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 45	0.1 Points on scale Standard Deviation 0.2	1.0 Points on scale Standard Deviation 1.2	0.8 Points on scale Standard Deviation 0.7	—	0.3 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 34	1.3 Points on scale Standard Deviation 2.4	0.8 Points on scale Standard Deviation 0.5	0.2 Points on scale Standard Deviation 0.2	—	0.2 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 35	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	1.2 Points on scale Standard Deviation 0.7	0.3 Points on scale Standard Deviation 0.3	0.6 Points on scale Standard Deviation 0.9	0.4 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 36	0.2 Points on scale Standard Deviation 0.3	1.2 Points on scale Standard Deviation 0.6	0.5 Points on scale Standard Deviation 0.3	—	0.1 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 37	0.1 Points on scale Standard Deviation 0.1	1.1 Points on scale Standard Deviation 0.8	0.4 Points on scale Standard Deviation 0.4	—	0.2 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 38	0.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	1.5 Points on scale Standard Deviation 0.4	0.4 Points on scale Standard Deviation 0.4	—	0.3 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 39	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	1.5 Points on scale Standard Deviation 0.5	0.7 Points on scale Standard Deviation 0.9	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.3 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 40	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.9 Points on scale Standard Deviation 0.4	0.5 Points on scale Standard Deviation 0.4	—	0.1 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 41	0.7 Points on scale Standard Deviation 1.6	1.4 Points on scale Standard Deviation 1.2	0.6 Points on scale Standard Deviation 0.6	—	0.3 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 42	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.3 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.5 Points on scale Standard Deviation 0.5	—	0.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 43	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.3 Points on scale Standard Deviation 0.4	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.4 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 44	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation 0.3	1.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 46	0.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	1.1 Points on scale Standard Deviation 0.7	—	0.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 47	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.4 Points on scale Standard Deviation 0.6	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 48	0.8 Points on scale Standard Deviation 0.9	0.2 Points on scale Standard Deviation 0.2	—	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 49	0.0 Points on scale Standard Deviation 0.0	1.1 Points on scale Standard Deviation 1.4	0.6 Points on scale Standard Deviation 0.6	—	0.3 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 50	0.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	1.0 Points on scale Standard Deviation 0.2	—	0.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 51	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation 0.2	—	0.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 52	0.4 Points on scale Standard Deviation 0.5	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.4 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 53	0.7 Points on scale Standard Deviation 1.5	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.2 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 54	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.8 Points on scale Standard Deviation 0.6	—	0.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 55	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.3 Points on scale Standard Deviation 0.5	—	0.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 56	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.0 Points on scale Standard Deviation 0.1	0.6 Points on scale Standard Deviation 0.3	—	—	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 57	0.0 Points on scale Standard Deviation 0.0	1.5 Points on scale Standard Deviation 2.1	0.3 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.2 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 58	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.7 Points on scale Standard Deviation 0.6	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 59	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.0 Points on scale Standard Deviation 0.1	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 60	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.4 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 61	0.3 Points on scale Standard Deviation 0.5	1.5 Points on scale Standard Deviation 2.1	0.4 Points on scale Standard Deviation 0.3	—	0.3 Points on scale Standard Deviation 0.5	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 62	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.7 Points on scale Standard Deviation 1.0	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 63	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.4 Points on scale Standard Deviation 0.7	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 64	1.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation 0.2	0.4 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 65	0.0 Points on scale Standard Deviation 0.0	0.8 Points on scale Standard Deviation 1.3	0.2 Points on scale Standard Deviation 0.0	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 66	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.6 Points on scale Standard Deviation 0.7	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 67	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation 0.3	—	0.9 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 28	1.2 Points on scale Standard Deviation 2.6	0.5 Points on scale Standard Deviation 0.7	0.5 Points on scale Standard Deviation 0.6	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 27	1.1 Points on scale Standard Deviation 2.5	0.5 Points on scale Standard Deviation 0.6	0.3 Points on scale Standard Deviation 0.3	0.1 Points on scale Standard Deviation 0.1	0.4 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Baseline	0.5 Points on scale Standard Deviation 1.1	0.4 Points on scale Standard Deviation 0.6	0.2 Points on scale Standard Deviation 0.3	0.6 Points on scale Standard Deviation 0.7	0.8 Points on scale Standard Deviation 1.6	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 1	—	—	0.3 Points on scale Standard Deviation 0.4	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 2	0.5 Points on scale Standard Deviation 1.3	0.3 Points on scale Standard Deviation 0.4	0.3 Points on scale Standard Deviation 0.4	1.0 Points on scale Standard Deviation 1.1	0.2 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 3	0.7 Points on scale Standard Deviation 1.5	0.1 Points on scale Standard Deviation 0.1	0.2 Points on scale Standard Deviation 0.5	0.9 Points on scale Standard Deviation 0.1	0.0 Points on scale Standard Deviation 0.1	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 5	0.6 Points on scale Standard Deviation 1.4	0.3 Points on scale Standard Deviation 0.5	0.2 Points on scale Standard Deviation 0.3	0.6 Points on scale Standard Deviation 0.6	0.1 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 6	0.8 Points on scale Standard Deviation 1.8	0.3 Points on scale Standard Deviation 0.5	0.2 Points on scale Standard Deviation 0.4	0.7 Points on scale Standard Deviation 1.0	0.1 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 7	0.9 Points on scale Standard Deviation 1.9	0.2 Points on scale Standard Deviation 0.3	0.3 Points on scale Standard Deviation 0.4	0.4 Points on scale Standard Deviation 0.6	0.0 Points on scale Standard Deviation 0.1	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 9	0.5 Points on scale Standard Deviation 0.9	0.2 Points on scale Standard Deviation 0.3	0.4 Points on scale Standard Deviation 0.9	0.5 Points on scale Standard Deviation 0.7	0.1 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 12	0.9 Points on scale Standard Deviation 2.0	0.3 Points on scale Standard Deviation 0.4	0.5 Points on scale Standard Deviation 1.4	0.3 Points on scale Standard Deviation 0.6	0.2 Points on scale Standard Deviation 0.2	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 13	0.6 Points on scale Standard Deviation 1.6	0.3 Points on scale Standard Deviation 0.4	0.7 Points on scale Standard Deviation 1.2	0.2 Points on scale Standard Deviation 0.4	0.3 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 15	0.7 Points on scale Standard Deviation 1.7	0.4 Points on scale Standard Deviation 0.5	0.2 Points on scale Standard Deviation 0.3	0.4 Points on scale Standard Deviation 0.4	0.9 Points on scale Standard Deviation 1.6	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 16	0.8 Points on scale Standard Deviation 1.8	0.4 Points on scale Standard Deviation 0.4	0.4 Points on scale Standard Deviation 0.5	0.4 Points on scale Standard Deviation 0.5	0.3 Points on scale Standard Deviation 0.7	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 17	0.8 Points on scale Standard Deviation 1.8	0.5 Points on scale Standard Deviation 0.7	0.2 Points on scale Standard Deviation 0.3	0.4 Points on scale Standard Deviation 0.6	0.3 Points on scale Standard Deviation 0.5	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 25	0.2 Points on scale Standard Deviation 0.2	0.3 Points on scale Standard Deviation 0.4	0.2 Points on scale Standard Deviation 0.2	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation 0.1	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 18	0.7 Points on scale Standard Deviation 1.8	0.3 Points on scale Standard Deviation 0.4	0.2 Points on scale Standard Deviation 0.3	0.1 Points on scale Standard Deviation 0.1	0.3 Points on scale Standard Deviation 0.5	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 19	0.8 Points on scale Standard Deviation 2.0	0.4 Points on scale Standard Deviation 0.7	0.2 Points on scale Standard Deviation 0.3	0.5 Points on scale Standard Deviation 0.8	0.3 Points on scale Standard Deviation 0.5	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 20	0.8 Points on scale Standard Deviation 1.9	0.6 Points on scale Standard Deviation 0.8	0.0 Points on scale Standard Deviation 0.2	0.1 Points on scale Standard Deviation 0.1	0.3 Points on scale Standard Deviation 0.4	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 21	0.9 Points on scale Standard Deviation 1.9	0.5 Points on scale Standard Deviation 0.5	0.3 Points on scale Standard Deviation 0.3	0.1 Points on scale Standard Deviation 0.1	0.3 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 22	0.8 Points on scale Standard Deviation 2.0	0.9 Points on scale Standard Deviation 1.5	0.2 Points on scale Standard Deviation 0.2	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.5 Points on scale Standard Deviation 0.6	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 23	0.8 Points on scale Standard Deviation 2.2	0.6 Points on scale Standard Deviation 0.7	0.2 Points on scale Standard Deviation 0.3	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.5 Points on scale Standard Deviation 0.6	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 24	1.0 Points on scale Standard Deviation 2.3	0.5 Points on scale Standard Deviation 0.7	0.4 Points on scale Standard Deviation 0.6	0.0 Points on scale Standard Deviation 0.1	0.3 Points on scale Standard Deviation 0.3	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 26	3.3 Points on scale Standard Deviation 4.4	0.4 Points on scale Standard Deviation 0.6	0.6 Points on scale Standard Deviation 0.8	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 99	—	0.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 68	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	1.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 69	0.3 Points on scale Standard Deviation 0.5	1.5 Points on scale Standard Deviation 2.1	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 70	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.7 Points on scale Standard Deviation 1.0	—	1.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 71	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.1 Points on scale Standard Deviation 0.1	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 72	1.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.9 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 73	0.0 Points on scale Standard Deviation 0.0	1.3 Points on scale Standard Deviation 1.8	0.4 Points on scale Standard Deviation 0.3	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 74	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	1.3 Points on scale Standard Deviation 0.7	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 75	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.2 Points on scale Standard Deviation 0.0	—	1.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 76	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 77	—	1.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.9 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 78	—	1.4 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 79	—	1.4 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 80	—	1.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 81	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 82	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 83	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 84	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 85	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 86	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.6 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 89	—	—	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 90	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 91	—	—	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 92	—	—	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 93	—	—	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 94	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 95	—	0.5 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 96	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 97	—	—	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 98	—	0.0 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 100	—	0.3 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 101	—	—	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 102	—	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 103	—	0.3 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 104	—	0.2 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 105	—	0.1 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	0.8 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 107	—	—	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F Week 108	—	—	—	—	0.7 Points on scale Standard Deviation NA SD is not evaluable when only one participant is analyzed	—	—	—	—	—
Symptom Severity and Interference According to Therapy-Induced Neuropathy Assessment Score (TINAS) in Arms A-F End of Treatment	0.6 Points on scale Standard Deviation 1.8	0.5 Points on scale Standard Deviation 0.8	0.4 Points on scale Standard Deviation 0.6	0.8 Points on scale Standard Deviation 1.0	0.1 Points on scale Standard Deviation 0.2	—	—	—	—	—

Adverse Events

Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL

Serious events: 2 serious events

Other events: 6 other events

Deaths: 2 deaths

Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL

Serious events: 4 serious events

Other events: 6 other events

Deaths: 2 deaths

Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL

Serious events: 5 serious events

Other events: 6 other events

Deaths: 4 deaths

Arm A (Phase II Randomization): Pola+BR in FL

Serious events: 25 serious events

Other events: 38 other events

Deaths: 16 deaths

Arm B (Phase II Randomization): BR in FL

Serious events: 12 serious events

Other events: 39 other events

Deaths: 11 deaths

Arm C (Phase II Randomization): Pola+BR in DLBCL

Serious events: 24 serious events

Other events: 36 other events

Deaths: 26 deaths

Arm D (Phase II Randomization): BR in DLBCL

Serious events: 27 serious events

Other events: 37 other events

Deaths: 30 deaths

Arm E (Phase II Expansion): Pola+BG in FL

Serious events: 8 serious events

Other events: 20 other events

Deaths: 3 deaths

Arm F (Phase II Expansion): Pola+BG in DLBCL

Serious events: 13 serious events

Other events: 19 other events

Deaths: 18 deaths

Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL

Serious events: 57 serious events

Other events: 103 other events

Deaths: 65 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 participants at risk Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 participants at risk Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=6 participants at risk Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=6 participants at risk Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm A (Phase II Randomization): Pola+BR in FL n=38 participants at risk Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm B (Phase II Randomization): BR in FL n=41 participants at risk Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm C (Phase II Randomization): Pola+BR in DLBCL n=39 participants at risk Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm D (Phase II Randomization): BR in DLBCL n=39 participants at risk Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm E (Phase II Expansion): Pola+BG in FL n=20 participants at risk Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=20 participants at risk Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 participants at risk Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.8% 6/38 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	8.5% 9/106 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders LYMPHOPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders ATRIAL FIBRILLATION	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders ATRIAL FLUTTER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders CARDIAC ARREST	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders CARDIAC FAILURE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders CARDIOMYOPATHY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders MYOCARDIAL ISCHAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders SUPRAVENTRICULAR TACHYCARDIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders TACHYCARDIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ASCITES	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders COLITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders CONSTIPATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders DIARRHOEA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders DUODENAL ULCER HAEMORRHAGE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ENTERITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders GASTRITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders MOUTH ULCERATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders NAUSEA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders OBSTRUCTION GASTRIC	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders PANCREATITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders VOMITING	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders ASTHENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders DEATH	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders MULTIPLE ORGAN DYSFUNCTION SYNDROME	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders OEDEMA PERIPHERAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders PYREXIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	6.6% 7/106 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders SUDDEN DEATH	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Hepatobiliary disorders HYPERTRANSAMINASAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Hepatobiliary disorders ISCHAEMIC HEPATITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ABDOMINAL ABSCESS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ABDOMINAL INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ARTHRITIS BACTERIAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations BACTERAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations BACTERIAL INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations BRONCHITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CEREBRAL TOXOPLASMOSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CLOSTRIDIAL SEPSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CYTOMEGALOVIRUS CHORIORETINITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CYTOMEGALOVIRUS COLITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CYTOMEGALOVIRUS ENTERITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CYTOMEGALOVIRUS INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations DEVICE RELATED INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations DIVERTICULITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ENTEROCOLITIS VIRAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ESCHERICHIA BACTERAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations GASTROENTERITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations GASTROINTESTINAL BACTERIAL INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations GIARDIASIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations HEPATITIS E	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations HERPES VIRUS INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations HERPES ZOSTER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations HUMAN ANAPLASMOSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations INFECTED LYMPHOCELE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations LARGE INTESTINE INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations MENINGOENCEPHALITIS HERPETIC	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations NEUTROPENIC SEPSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations OESOPHAGEAL CANDIDIASIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ORAL INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PARONYCHIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PLEURAL INFECTION BACTERIAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PNEUMOCYSTIS JIROVECII PNEUMONIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PNEUMONIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	18.4% 7/38 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.7% 6/106 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PNEUMONIA BACTERIAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PNEUMONIA CYTOMEGALOVIRAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PNEUMONIA FUNGAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PNEUMONIA PNEUMOCOCCAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PNEUMONIA VIRAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations POST PROCEDURAL INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations RHINOVIRUS INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations SEPSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	6.6% 7/106 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations SEPTIC SHOCK	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations UROSEPSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications FALL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications HEAD INJURY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications POST PROCEDURAL FEVER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations BLOOD CREATININE INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations MORAXELLA TEST POSITIVE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations TRANSAMINASES INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations WEIGHT DECREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA GASTRIC	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA OF COLON	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL ADENOCARCINOMA	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL CANCER	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INTESTINAL ADENOCARCINOMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LYMPHOCYTIC LEUKAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders CAROTID ARTERY OCCLUSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders CEREBRAL INFARCTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders CEREBRAL ISCHAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders HYDROCEPHALUS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders LEUKOENCEPHALOPATHY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders SEIZURE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders VOCAL CORD PARALYSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders HAEMATURIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders HYDRONEPHROSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders RENAL FAILURE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders ACUTE PULMONARY OEDEMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders BRONCHOPNEUMOPATHY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders HYPERVENTILATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders RASH	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders RASH ERYTHEMATOUS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders DISTRIBUTIVE SHOCK	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders HYPOTENSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders THROMBOPHLEBITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders ATRIAL THROMBOSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ENTEROCOLITIS HAEMORRHAGIC	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations COVID-19 PNEUMONIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations DISSEMINATED VARICELLA ZOSTER VIRUS INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations VASCULAR ACCESS SITE CELLULITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) EPIGLOTTIC CANCER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PANCREATIC CARCINOMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders BRAIN OEDEMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.

Other adverse events

Other adverse events
Measure	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in FL n=6 participants at risk Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1a (Phase Ib Safety Run-In): Pola+BR in DLBCL n=6 participants at risk Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine, 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in FL n=6 participants at risk Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Cohort 1b (Phase Ib Safety Run-In): Pola+BG in DLBCL n=6 participants at risk Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm A (Phase II Randomization): Pola+BR in FL n=38 participants at risk Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm B (Phase II Randomization): BR in FL n=41 participants at risk Participants with FL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 28 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm C (Phase II Randomization): Pola+BR in DLBCL n=39 participants at risk Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.	Arm D (Phase II Randomization): BR in DLBCL n=39 participants at risk Participants with DLBCL received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1 (each cycle is 21 days), thereafter on Days 1 and 2 of Cycles 2 to 6 in combination with rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6.	Arm E (Phase II Expansion): Pola+BG in FL n=20 participants at risk Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm F (Phase II Expansion): Pola+BG in DLBCL n=20 participants at risk Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.	Arm G+H (Phase II NF Cohort): Pola+BR in DLBCL n=106 participants at risk Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
Gastrointestinal disorders APHTHOUS ULCER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders CONSTIPATION	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	66.7% 4/6 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	26.3% 10/38 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	19.5% 8/41 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	20.5% 8/39 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	17.9% 7/39 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	35.0% 7/20 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	45.0% 9/20 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	18.9% 20/106 • Number of events 27 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders DIARRHOEA	33.3% 2/6 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	66.7% 4/6 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	66.7% 4/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	42.1% 16/38 • Number of events 27 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	22.0% 9/41 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	28.2% 11/39 • Number of events 13 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	41.0% 16/39 • Number of events 28 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 10/20 • Number of events 22 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	55.0% 11/20 • Number of events 18 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	34.0% 36/106 • Number of events 48 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders DRY MOUTH	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders DYSPEPSIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.5% 4/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	14.6% 6/41 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders FLATULENCE	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders NAUSEA	50.0% 3/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	83.3% 5/6 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	57.9% 22/38 • Number of events 35 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	31.7% 13/41 • Number of events 25 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	41.0% 16/39 • Number of events 19 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	30.8% 12/39 • Number of events 14 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	55.0% 11/20 • Number of events 21 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	55.0% 11/20 • Number of events 16 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	32.1% 34/106 • Number of events 38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ODYNOPHAGIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders STOMATITIS	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	13.2% 5/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders VOMITING	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	83.3% 5/6 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	18.4% 7/38 • Number of events 12 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	19.5% 8/41 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	17.9% 7/39 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	40.0% 8/20 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	40.0% 8/20 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.0% 17/106 • Number of events 18 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders ASTHENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	18.4% 7/38 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.4% 6/39 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	11.3% 12/106 • Number of events 13 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders CHILLS	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.0% 5/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders DISCOMFORT	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders FATIGUE	66.7% 4/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	66.7% 4/6 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	42.1% 16/38 • Number of events 20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	31.7% 13/41 • Number of events 22 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	35.9% 14/39 • Number of events 17 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	35.9% 14/39 • Number of events 20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	65.0% 13/20 • Number of events 22 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	60.0% 12/20 • Number of events 15 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	20.8% 22/106 • Number of events 25 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders MUCOSAL INFLAMMATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders OEDEMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders OEDEMA PERIPHERAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	9.8% 4/41 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.7% 6/106 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders PYREXIA	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	21.1% 8/38 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	9.8% 4/41 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	23.1% 9/39 • Number of events 15 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.6% 10/39 • Number of events 14 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	40.0% 8/20 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	20.8% 22/106 • Number of events 27 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Immune system disorders HYPOGAMMAGLOBULINAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders ANAEMIA	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.8% 6/38 • Number of events 24 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.2% 5/41 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.6% 10/39 • Number of events 13 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	48.7% 19/39 • Number of events 28 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.0% 5/20 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.5% 27/106 • Number of events 35 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 19 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	6.6% 7/106 • Number of events 17 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders LYMPHOPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders NEUTROPENIA	33.3% 2/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	42.1% 16/38 • Number of events 31 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	26.8% 11/41 • Number of events 18 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	35.9% 14/39 • Number of events 27 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	53.8% 21/39 • Number of events 63 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	30.0% 6/20 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	30.0% 6/20 • Number of events 30 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.0% 35/106 • Number of events 73 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders THROMBOCYTOPENIA	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	19.5% 8/41 • Number of events 13 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	28.2% 11/39 • Number of events 18 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	48.7% 19/39 • Number of events 50 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	20.0% 4/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	35.0% 7/20 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	17.9% 19/106 • Number of events 40 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders TACHYCARDIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.7% 6/106 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Ear and labyrinth disorders HYPOACUSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ABDOMINAL PAIN	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.8% 6/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.2% 5/41 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	11.3% 12/106 • Number of events 14 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.7% 6/106 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations BRONCHITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations HERPES VIRUS INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations HERPES ZOSTER	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.5% 4/38 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations NASOPHARYNGITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ORAL HERPES	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations PNEUMONIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.7% 6/106 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.5% 4/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations SINUSITIS	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	17.1% 7/41 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.0% 5/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	6.6% 7/106 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	6.6% 7/106 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications FALL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	13.2% 5/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.2% 5/41 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications LIMB INJURY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	6.6% 7/106 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations BLOOD CREATININE INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations C-REACTIVE PROTEIN INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.7% 6/106 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations HAEMOGLOBIN DECREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations LIPASE INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations LYMPHOCYTE COUNT DECREASED	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.5% 8/106 • Number of events 16 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 15 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	13.2% 14/106 • Number of events 37 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations PLATELET COUNT DECREASED	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 18 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.5% 8/106 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations WEIGHT DECREASED	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	13.2% 14/106 • Number of events 14 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations WEIGHT INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 16 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	8.5% 9/106 • Number of events 29 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders DECREASED APPETITE	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	26.3% 10/38 • Number of events 13 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.2% 5/41 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	20.5% 8/39 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.6% 10/39 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	30.0% 6/20 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	40.0% 8/20 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.5% 27/106 • Number of events 30 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPERGLYCAEMIA	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPERURICAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPOKALAEMIA	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	13.2% 5/38 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	9.8% 4/41 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.0% 5/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	14.2% 15/106 • Number of events 20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	16.7% 1/6 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.5% 4/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	20.0% 4/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.3% 13/106 • Number of events 18 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.7% 6/106 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	6.6% 7/106 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders BONE PAIN	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders MYALGIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders DIZZINESS	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.5% 4/38 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.2% 5/41 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	9.4% 10/106 • Number of events 11 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders DYSGEUSIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders HEADACHE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	21.1% 8/38 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.2% 5/41 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	30.0% 6/20 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	11.3% 12/106 • Number of events 14 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders HYPOAESTHESIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders NEUROPATHY PERIPHERAL	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.8% 6/38 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.2% 5/41 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	23.1% 9/39 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	25.0% 5/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	14.2% 15/106 • Number of events 16 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders PARAESTHESIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	13.2% 5/38 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	13.2% 5/38 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.4% 6/39 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders POST HERPETIC NEURALGIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders SYNCOPE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Psychiatric disorders ANXIETY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Psychiatric disorders DEPRESSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Psychiatric disorders INSOMNIA	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.5% 8/106 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders DYSURIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders POLLAKIURIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders COUGH	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.8% 6/38 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	20.5% 8/39 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.4% 6/39 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.3% 13/106 • Number of events 16 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.5% 4/38 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	9.8% 4/41 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	35.0% 7/20 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	30.0% 6/20 • Number of events 7 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.5% 4/38 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.7% 3/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders THROAT IRRITATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders UPPER-AIRWAY COUGH SYNDROME	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders ALOPECIA	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	50.0% 3/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders DRY SKIN	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 10 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders NIGHT SWEATS	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders PRURITUS	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	9.8% 4/41 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.3% 4/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.5% 8/106 • Number of events 9 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders RASH	33.3% 2/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.9% 3/38 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	9.8% 4/41 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.7% 5/106 • Number of events 8 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders URTICARIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	33.3% 2/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders DEEP VEIN THROMBOSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders FLUSHING	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	7.3% 3/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders HYPERTENSION	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	10.0% 2/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders HYPOTENSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	12.8% 5/39 • Number of events 5 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	15.0% 3/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	9.4% 10/106 • Number of events 12 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders COAGULOPATHY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders HAEMOLYSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders HAEMOLYTIC ANAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders LYMPHADENOPATHY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders BUNDLE BRANCH BLOCK RIGHT	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders SINUS TACHYCARDIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders VENTRICULAR TACHYCARDIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Ear and labyrinth disorders EAR PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Eye disorders EYE DISCHARGE	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Eye disorders EYE PRURITUS	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Eye disorders GLAUCOMA	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Eye disorders OCULAR HYPERAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Eye disorders VISION BLURRED	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders ANAL SPASM	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders COLITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders DEFAECATION URGENCY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders DIVERTICULUM	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders GINGIVAL BLEEDING	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders GINGIVAL DISORDER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders GINGIVAL PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders LIP DRY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders MOUTH ULCERATION	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders NONINFECTIVE GINGIVITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders RECTAL DISCHARGE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders CATHETER SITE PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders CATHETER SITE PRURITUS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders CHEST DISCOMFORT	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders CHEST PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders EARLY SATIETY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders GAIT DISTURBANCE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
General disorders PERIPHERAL SWELLING	16.7% 1/6 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Immune system disorders HYPERSENSITIVITY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CANDIDA INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CELLULITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CLOSTRIDIUM DIFFICILE INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CYSTITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CYTOMEGALOVIRUS INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations CYTOMEGALOVIRUS VIRAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations EAR INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ESCHERICHIA URINARY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations FOLLICULITIS	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations ORAL CANDIDIASIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations RASH PUSTULAR	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations SKIN INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications ARTHROPOD BITE	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications COMMINUTED FRACTURE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Injury, poisoning and procedural complications WOUND	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations AMYLASE INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations BLOOD CALCIUM DECREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations BLOOD MAGNESIUM DECREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations BLOOD PHOSPHORUS DECREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations HEPATIC ENZYME INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations LIVER FUNCTION TEST ABNORMAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations NEUTROPHIL COUNT INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations TRANSAMINASES INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations TROPONIN I INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Investigations TROPONIN INCREASED	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders LACTIC ACIDOSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders MALNUTRITION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders CERVICAL SPINAL STENOSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC DEGENERATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 3 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders MUSCLE TIGHTNESS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HODGKIN'S DISEASE	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders AMNESIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders DYSKINESIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders LETHARGY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders NEURALGIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders PERONEAL NERVE PALSY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders POLYNEUROPATHY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders RESTLESS LEGS SYNDROME	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders SCIATICA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders SINUS HEADACHE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders SOMNOLENCE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders TASTE DISORDER	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Nervous system disorders TREMOR	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	4.9% 2/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Psychiatric disorders DELIRIUM	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Psychiatric disorders IRRITABILITY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Psychiatric disorders MENTAL STATUS CHANGES	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	3.8% 4/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders ANURIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders HAEMATURIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.8% 3/106 • Number of events 4 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders RENAL FAILURE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Renal and urinary disorders URINARY RETENTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Reproductive system and breast disorders ERECTILE DYSFUNCTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.3% 2/38 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Reproductive system and breast disorders TESTICULAR PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Reproductive system and breast disorders TESTICULAR SWELLING	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Reproductive system and breast disorders VAGINAL DISCHARGE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders HICCUPS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders NASAL DISCHARGE DISCOLOURATION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders ORGANISING PNEUMONIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	1.9% 2/106 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders PULMONARY OEDEMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders SINUS PAIN	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders TACHYPNOEA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders RASH MACULAR	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.94% 1/106 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Skin and subcutaneous tissue disorders SKIN DISCOLOURATION	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders EMBOLISM	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders ORTHOSTATIC HYPOTENSION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/38 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.4% 1/41 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders PALLOR	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Vascular disorders PHLEBITIS SUPERFICIAL	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	2.6% 1/39 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Blood and lymphatic system disorders IMMUNE THROMBOCYTOPENIA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Cardiac disorders ATRIOVENTRICULAR BLOCK FIRST DEGREE	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.1% 2/39 • Number of events 2 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Infections and infestations VASCULAR ACCESS SITE INFECTION	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	16.7% 1/6 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ENDOMETRIAL ADENOCARCINOMA	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/6 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/38 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/41 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/39 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	5.0% 1/20 • Number of events 1 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/20 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.	0.00% 0/106 • From Baseline up to study completion/discontinuation (up to approximately 84 months) All-Cause Mortality were reported for the ITT population. ITT population=participants who were randomized, whether or not the participants received the assigned treatment. Serious and non-serious adverse events were reported for safety population. Safety population=participants who received at least one dose of study medication.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800 821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER