Trial Outcomes & Findings for Dose Escalation and Double-blind Study of Veliparib in Combination With Carboplatin and Etoposide in Treatment-naive Extensive Stage Disease Small Cell Lung Cancer (NCT NCT02289690)

NCT ID: NCT02289690

Last Updated: 2020-05-14

Results Overview

A DLT was defined as any of the following drug-related toxicities, graded according to the Common Toxicity Criteria for Adverse Events (CTCAE), V.4.0: 1. Events associated with treatment delay \>14 days in initiating Cycle 2 therapy: Grade 4 thrombocytopenia, neutropenia, or febrile neutropenia, or Grade 3 febrile neutropenia with fever for \> 7 days 2. Grade ≥ 3 non-hematologic toxicity with ≥ 2 grade increase from baseline and attributed to veliparib treatment, excluding nausea or vomiting for ≤ 48 hours or inadequately treated, electrolyte abnormalities resolving in ≤ 24 hours, hypersensitivity reactions or alopecia 3. Grade 2 non-hematologic toxicity of ≥ 2 grade increase from baseline, attributed to veliparib treatment requiring delay of \>14 days in initiation of Cycle 2 4. Any toxicity of ≥ 2-grade increase from baseline, attributed to veliparib and requiring a dose modification in Cycle 1 or omission of carboplatin, \>1 daily etoposide dose, or \>30% veliparib doses in Cycle 1

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 221 participants
• Primary outcome timeframe: Cycle 1 Day -2 to pre-dose on Cycle 2 Day 1 (23 days)
• Results posted on: 2020-05-14

Participant Flow

The study was conducted at 52 study sites located in 12 countries (Australia, Belgium, Canada, Czech Republic, France, Hungary, Korea, the Netherlands, Romania, Russian Federation, Spain, United States).

Participants in Phase 1 were sequentially assigned to ascending dose levels of veliparib in combination with standard carboplatin/etoposide regimen. Participants in Phase 2 were randomized equally to placebo, carboplatin/etoposide followed by placebo maintenance, or to veliparib, carboplatin/etoposide followed by veliparib or placebo maintenance.

Participant milestones

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Placebo + Carboplatin/Etoposide -> Placebo Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Overall Study STARTED	4	3	4	3	8	14	4	61	59	61
Overall Study Received Study Drug	4	3	4	3	8	14	4	60	58	60
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	4	3	4	3	8	14	4	61	59	61

Reasons for withdrawal

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Placebo + Carboplatin/Etoposide -> Placebo Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Overall Study Adverse Event Related to Progression	0	1	1	0	1	0	1	0	0	0
Overall Study Withdrawal by Subject	1	0	0	0	1	1	0	0	4	2
Overall Study Progressive Disease, Per Protocol	3	2	3	2	5	13	2	0	0	0
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	1	0	2
Overall Study Death	0	0	0	0	0	0	0	49	45	41
Overall Study Sponsor Discontinued Study	0	0	0	0	0	0	0	9	7	15
Overall Study Other	0	0	0	1	1	0	1	2	3	1

Baseline Characteristics

Phase 1 and Phase 2 were analyzed separately.

Baseline characteristics by cohort

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease pParticipants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=8 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide n=14 Participants Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide n=4 Participants Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib n=61 Participants Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo n=59 Participants Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Placebo + Carboplatin/Etoposide -> Placebo n=61 Participants Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Total n=221 Participants Total of all reporting groups
Sex: Female, Male Male	1 Participants n=4 Participants	3 Participants n=3 Participants	2 Participants n=4 Participants	2 Participants n=3 Participants	6 Participants n=8 Participants	9 Participants n=14 Participants	3 Participants n=4 Participants	40 Participants n=61 Participants	38 Participants n=59 Participants	38 Participants n=61 Participants	142 Participants n=221 Participants
Age, Continuous Phase 1	74.0 years n=4 Participants • Phase 1 and Phase 2 were analyzed separately.	69.0 years n=3 Participants • Phase 1 and Phase 2 were analyzed separately.	62.5 years n=4 Participants • Phase 1 and Phase 2 were analyzed separately.	54.0 years n=3 Participants • Phase 1 and Phase 2 were analyzed separately.	52.0 years n=8 Participants • Phase 1 and Phase 2 were analyzed separately.	66.0 years n=14 Participants • Phase 1 and Phase 2 were analyzed separately.	59.0 years n=4 Participants • Phase 1 and Phase 2 were analyzed separately.	—	—	—	62.5 years n=40 Participants • Phase 1 and Phase 2 were analyzed separately.
Age, Continuous Phase 2	—	—	—	—	—	—	—	62.0 years n=61 Participants • Phase 1 and Phase 2 were analyzed separately.	64.0 years n=59 Participants • Phase 1 and Phase 2 were analyzed separately.	63.0 years n=61 Participants • Phase 1 and Phase 2 were analyzed separately.	63.0 years n=181 Participants • Phase 1 and Phase 2 were analyzed separately.
Sex: Female, Male Female	3 Participants n=4 Participants	0 Participants n=3 Participants	2 Participants n=4 Participants	1 Participants n=3 Participants	2 Participants n=8 Participants	5 Participants n=14 Participants	1 Participants n=4 Participants	21 Participants n=61 Participants	21 Participants n=59 Participants	23 Participants n=61 Participants	79 Participants n=221 Participants
Race/Ethnicity, Customized White	4 Participants n=4 Participants	3 Participants n=3 Participants	4 Participants n=4 Participants	3 Participants n=3 Participants	8 Participants n=8 Participants	14 Participants n=14 Participants	4 Participants n=4 Participants	55 Participants n=61 Participants	51 Participants n=59 Participants	52 Participants n=61 Participants	198 Participants n=221 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	2 Participants n=61 Participants	1 Participants n=59 Participants	1 Participants n=61 Participants	4 Participants n=221 Participants
Race/Ethnicity, Customized Asian	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	4 Participants n=61 Participants	7 Participants n=59 Participants	7 Participants n=61 Participants	18 Participants n=221 Participants
Race/Ethnicity, Customized Missing	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=8 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	0 Participants n=61 Participants	0 Participants n=59 Participants	1 Participants n=61 Participants	1 Participants n=221 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - Fully active	1 Participants n=4 Participants	1 Participants n=3 Participants	1 Participants n=4 Participants	1 Participants n=3 Participants	2 Participants n=8 Participants	3 Participants n=14 Participants	2 Participants n=4 Participants	21 Participants n=61 Participants	16 Participants n=59 Participants	23 Participants n=61 Participants	71 Participants n=221 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1 - Restricted but ambulatory	3 Participants n=4 Participants	2 Participants n=3 Participants	3 Participants n=4 Participants	2 Participants n=3 Participants	5 Participants n=8 Participants	11 Participants n=14 Participants	1 Participants n=4 Participants	39 Participants n=61 Participants	42 Participants n=59 Participants	37 Participants n=61 Participants	145 Participants n=221 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Missing	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=4 Participants	0 Participants n=3 Participants	1 Participants n=8 Participants	0 Participants n=14 Participants	1 Participants n=4 Participants	1 Participants n=61 Participants	1 Participants n=59 Participants	1 Participants n=61 Participants	5 Participants n=221 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day -2 to pre-dose on Cycle 2 Day 1 (23 days)

Population: Phase 1 participants who received at least 1 dose of study drug

A DLT was defined as any of the following drug-related toxicities, graded according to the Common Toxicity Criteria for Adverse Events (CTCAE), V.4.0:

1. Events associated with treatment delay >14 days in initiating Cycle 2 therapy:

Grade 4 thrombocytopenia, neutropenia, or febrile neutropenia, or Grade 3 febrile neutropenia with fever for > 7 days

2. Grade ≥ 3 non-hematologic toxicity with ≥ 2 grade increase from baseline and attributed to veliparib treatment, excluding nausea or vomiting for ≤ 48 hours or inadequately treated, electrolyte abnormalities resolving in ≤ 24 hours, hypersensitivity reactions or alopecia

3. Grade 2 non-hematologic toxicity of ≥ 2 grade increase from baseline, attributed to veliparib treatment requiring delay of >14 days in initiation of Cycle 2

4. Any toxicity of ≥ 2-grade increase from baseline, attributed to veliparib and requiring a dose modification in Cycle 1 or omission of carboplatin, >1 daily etoposide dose, or >30% veliparib doses in Cycle 1

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=8 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide n=14 Participants Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide n=4 Participants Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Number of Participants With Dose-limiting Toxicities (DLTs)	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants

PRIMARY outcome

Timeframe: Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

Population: Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom Cmax could be calculated.

Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Veliparib	0.620 μg/mL Geometric Coefficient of Variation 17	1.00 μg/mL Geometric Coefficient of Variation 31	1.39 μg/mL Geometric Coefficient of Variation 29	1.44 μg/mL Geometric Coefficient of Variation 10	1.99 μg/mL Geometric Coefficient of Variation 25	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

Population: Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom Tmax could be calculated.

Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Veliparib	2.0 hours Interval 1.0 to 2.0	1.0 hours Interval 1.0 to 2.0	1.5 hours Interval 1.0 to 2.0	2.0 hours Interval 1.0 to 2.0	1.0 hours Interval 1.0 to 3.0	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

Population: Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom AUC(0-8) could be calculated.

The area under the plasma concentration-time curve from time 0 to 8 hours post-dose for veliparib was estimated using non-compartmental methods.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=2 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose (AUC[0-8]) of Veliparib	3.18 μg*h/mL Geometric Coefficient of Variation 14	4.24 μg*h/mL Geometric Coefficient of Variation 25	7.51 μg*h/mL Geometric Coefficient of Variation 28	6.66 μg*h/mL Geometric Coefficient of Variation 4	9.29 μg*h/mL Geometric Coefficient of Variation 37	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

Population: Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom AUC(0-12) could be calculated.

The area under the plasma concentration-time curve from time 0 to 12 hours post-dose for veliparib was estimated using non-compartmental methods. AUC(0-12) was calculated by assuming the concentration at 12 hours post-dose was the same as the pre-dose concentration.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose (AUC[0-12]) of Veliparib	4.07 μg*h/mL Geometric Coefficient of Variation 15	5.25 μg*h/mL Geometric Coefficient of Variation 27	9.71 μg*h/mL Geometric Coefficient of Variation 31	8.35 μg*h/mL Geometric Coefficient of Variation 6	11.6 μg*h/mL Geometric Coefficient of Variation 40	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

Population: Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom Cmax could be calculated.

Plasma concentrations of veliparib were determined using a validated online solid-phase extraction followed by high-performance liquid chromatography with tandem mass spectrometric detection (HPLC LC-MS/MS). The lower limit of quantitation (LLOQ) for veliparib was established at ≥ 1.05 ng/mL.

Dose normalized Cmax is calculated as Cmax / veliparib dose in mg.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Dose-normalized Maximum Observed Plasma Concentration of Veliparib	7.75 (ng/mL)/mg Geometric Coefficient of Variation 16	8.35 (ng/mL)/mg Geometric Coefficient of Variation 31	8.66 (ng/mL)/mg Geometric Coefficient of Variation 29	7.19 (ng/mL)/mg Geometric Coefficient of Variation 10	8.31 (ng/mL)/mg Geometric Coefficient of Variation 25	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

Population: Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom AUC(0-8) could be calculated.

The area under the plasma concentration-time curve from time 0 to 8 hours post-dose for veliparib was estimated using non-compartmental methods. Dose normalized AUC(0-8) is calculated as AUC(0-8) / veliparib dose in mg.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=2 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Dose-normalized Area Under the Plasma Concentration-time Curve From Time 0 to 8 Hours Post-dose of Veliparib	39.8 (ng*h/mL)/mg Geometric Coefficient of Variation 14	35.3 (ng*h/mL)/mg Geometric Coefficient of Variation 25	46.9 (ng*h/mL)/mg Geometric Coefficient of Variation 28	33.3 (ng*h/mL)/mg Geometric Coefficient of Variation 4	38.7 (ng*h/mL)/mg Geometric Coefficient of Variation 37	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 predose and at 1, 2, 3, 5, 8, and 24 hours post-dose

Population: Phase 1 participants who were administered at least 1 dose of study drug, had at least 1 reported PK sample concentration and for whom AUC(0-12) could be calculated.

The area under the plasma concentration-time curve from time 0 to 12 hours post-dose for veliparib was estimated using non-compartmental methods. AUC(0-12) was calculated by assuming the concentration at 12 hours post-dose was the same as the pre-dose concentration. Dose normalized AUC(0-12) is calculated as AUC(0-12) / veliparib dose in mg.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Dose-normalized Area Under the Plasma Concentration-time Curve From Time 0 to 12 Hours Post-dose of Veliparib	50.9 (ng*h/mL)/mg Geometric Coefficient of Variation 15	43.8 (ng*h/mL)/mg Geometric Coefficient of Variation 27	60.7 (ng*h/mL)/mg Geometric Coefficient of Variation 31	41.7 (ng*h/mL)/mg Geometric Coefficient of Variation 6	48.5 (ng*h/mL)/mg Geometric Coefficient of Variation 40	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

Population: Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom Cmax could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group and participants whose etoposide dose was reduced in Cycle 2 are not included in the Cycle 2 Day 1 analysis.

Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=37 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=23 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Maximum Observed Plasma Concentration (Cmax) of Etoposide With and Without Veliparib	16.9 μg/mL Geometric Coefficient of Variation 18	16.4 μg/mL Geometric Coefficient of Variation 21	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

Population: Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom Tmax could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group are not included in the Cycle 2 Day 1 analysis.

Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=37 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=28 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Time to Maximum Observed Plasma Concentration (Tmax) of Etoposide With and Without Veliparib	0.9 hours Interval 0.8 to 3.0	0.9 hours Interval 0.9 to 3.7	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

Population: Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom AUC could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group and participants whose etoposide dose was reduced in Cycle 2 are not included in the Cycle 2 Day 1 analysis.

The area under the plasma concentration-time curve from 0 to the last measurable concentration (24 hours) of etoposide was estimated using using non-compartmental methods.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=35 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC[0-t]) of Etoposide With and Without Veliparib	102 μg*h/mL Geometric Coefficient of Variation 23	94.7 μg*h/mL Geometric Coefficient of Variation 18	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

Population: Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom AUC could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group and participants whose etoposide dose was reduced in Cycle 2 are not included in the Cycle 2 Day 1 analysis.

The area under the plasma concentration-time curve from 0 to infinity for etoposide was estimated using using non-compartmental methods.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=35 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=22 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) of Etoposide With and Without Veliparib	112 μg*h/mL Geometric Coefficient of Variation 56	99.5 μg*h/mL Geometric Coefficient of Variation 18	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

Population: Participants in Phase 1 who received at least 1 dose of study drug and had at least 1 reported PK sample concentration for each time point and for whom t1/2 could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group are not included in the Cycle 2 Day 1 analysis.

The terminal half-life of etoposide was estimated using using non-compartmental methods. Values reported represent the harmonic mean ± pseudo-standard deviation.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=35 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=27 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Terminal Phase Elimination Half-life (t1/2) of Etoposide With and Without Veliparib	5.7 hours Standard Deviation 1.5	5.0 hours Standard Deviation 1.2	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

Population: Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom Cmax could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group are not included in the Cycle 2 Day 1 analysis.

Etoposide plasma concentrations were determined using liquid chromatography with tandem mass spectrometric detection with a lower limit of quantitation 160 ng/mL. Dose normalized Cmax is calculated as Cmax / etoposide dose in mg/m².

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=37 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=28 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Dose-normalized Maximum Observed Plasma Concentration (Cmax) of Etoposide With and Without Veliparib	169 (ng/mL)/(mg/m²) Geometric Coefficient of Variation 18	170 (ng/mL)/(mg/m²) Geometric Coefficient of Variation 20	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

Population: Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom AUC could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group are not included in the Cycle 2 Day 1 analysis.

The area under the plasma concentration-time curve from 0 to the last measurable concentration (24 hours) of etoposide was estimated using using non-compartmental methods. Dose normalized AUC(0-t) is calculated as AUC(0-t) / etoposide dose in mg/m².

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=35 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=27 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Dose-normalized Area Under the Concentration-time Curve From Time 0 to Time of Last Measurable Concentration (AUC[0-t]) of Etoposide With and Without Veliparib	1020 (ng*h/mL)/(mg/m²) Geometric Coefficient of Variation 23	952 (ng*h/mL)/(mg/m²) Geometric Coefficient of Variation 21	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 Day 1 (coadministered with veliparib and carboplatin), and on Cycle 2 Day 1 (co-administered with carboplatin but in the absence of veliparib) at 55 minutes (5 minutes before the end of infusion) and 3, 5, 8, and 24 hours post-dose.

Population: Phase 1 participants who received at least 1 dose of study drug, had at least 1 reported PK concentration for each time point and for whom AUC could be calculated. Participants in the Veliparib 240 mg BID 21-day (continuous) dosing group are not included in the Cycle 2 Day 1 analysis.

The area under the plasma concentration-time curve from 0 to infinity for etoposide was estimated using using non-compartmental methods. Dose normalized AUC(0-∞) is calculated as AUC(0-∞) / etoposide dose in mg/m².

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=35 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=27 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Dose-normalized Area Under the Concentration-time Curve From Time 0 to Infinity (AUC[0-∞]) of Etoposide With and Without Veliparib	1120 (ng*h/mL)/(mg/m²) Geometric Coefficient of Variation 56	1020 (ng*h/mL)/(mg/m²) Geometric Coefficient of Variation 20	—	—	—	—	—

PRIMARY outcome

Timeframe: From randomization up to the date the 126th PFS event was reached; Median time on follow-up was 7.3, 7.1, and 8.9 months in each treatment group respectively.

Population: All participants randomized in Phase 2

Progression-free survival (PFS) is defined as the time from the date of randomization to the date of earliest radiographic disease progression or death provided no radiographic disease progression occurred.

If a participant did not have an event of disease progression and had not died on or prior to the cutoff for PFS analysis, the participant's data was censored at the date of their last disease assessment or randomization date provided participant did not have any post-baseline disease assessment.

Disease assessments were performed using computed tomography according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Progressive Disease (PD) was defined as at least a 20% increase in the size of target lesions and an absolute increase of at least 5 mm taking as reference the smallest lesion size recorded since the treatment started (baseline or after), or the appearance of one or more new lesions.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=61 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=59 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=61 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 2: Progression-free Survival	5.8 months Interval 5.6 to 6.8	5.7 months Interval 5.6 to 5.8	5.6 months Interval 5.1 to 6.7	—	—	—	—

SECONDARY outcome

Timeframe: From randomization until the end of study; median time on follow-up was 10.0, 8.6, and 11.7 months in each treatment group respectively.

Population: All participants randomized in Phase 2

Overall survival (OS) is defined as the time from the date of randomization to the date of death. If a participant did not die on or prior to the cut-off for OS analysis, the participant's data were censored at the date of their last known alive date, which is defined as the last date of the last survival follow-up visit, the start date of the last AE, the start date or end date of the last dose of any study drugs, the last lab and vital sign collection date, or the last disease assessment date, whichever occurred last.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=61 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=59 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=61 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 2: Overall Survival	10.1 months Interval 9.2 to 11.4	10.0 months Interval 8.0 to 12.7	12.4 months Interval 11.1 to 13.6	—	—	—	—

SECONDARY outcome

Timeframe: Tumor assessments were performed every 6 weeks for the first 30 weeks and every 9 weeks thereafter until disease progression; median time on follow-up was 7.3, 7.1, and 8.9 months in each group respectively.

Population: All participants randomized in Phase 2

Objective response rate (ORR) is defined as the percentage of participants with objective response (confirmed) as assessed by the investigator using RECIST version 1.1. Objective response includes both complete response (CR) and partial response (PR). Response must be confirmed at a subsequent tumor assessment at least 28 days apart. Participants with no post-baseline confirmed response were counted as non-responders.

CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. No new lesions.

PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, and no new lesions.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=61 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=59 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=61 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 2: Objective Response Rate	77.0 percentage of participants Interval 68.7 to 84.0	59.3 percentage of participants Interval 50.1 to 68.0	63.9 percentage of participants Interval 55.0 to 72.2	—	—	—	—

SECONDARY outcome

Timeframe: From first dose of any study drug to 30 days after the last dose; the median duration of treatment with veliparib across all groups in Phase 1 was 127.5 days.

Population: Participants in Phase 1 who received at least 1 dose of study drug.

The intensity of each adverse event (AE) was assessed utilizing the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, and according to the following: Grade 1 (Mild): AE is transient and easily tolerated by the participant; Grade 2 (Moderate): AE causes the participant discomfort and interrupts the participant's usual activities; Grade 3/4 (Severe): The adverse event causes considerable interference with the participant's usual activities and may be incapacitating or life-threatening; Grade 5: Death.

Serious adverse events were those that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in congenital anomaly, or persistent or significant disability/incapacity.

Outcome measures

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 Participants Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 Participants Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=8 Participants Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide n=14 Participants Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide n=4 Participants Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Phase 1: Number of Participants With Adverse Events Any adverse event	4 Participants	3 Participants	4 Participants	3 Participants	8 Participants	14 Participants	4 Participants
Phase 1: Number of Participants With Adverse Events Any fatal adverse event	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants
Phase 1: Number of Participants With Adverse Events Any AE Grade 3/4	4 Participants	3 Participants	4 Participants	3 Participants	7 Participants	14 Participants	4 Participants
Phase 1: Number of Participants With Adverse Events Any serious adverse event	3 Participants	1 Participants	3 Participants	2 Participants	3 Participants	6 Participants	3 Participants

Adverse Events

Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide

Serious events: 3 serious events

Other events: 4 other events

Deaths: 1 deaths

Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide

Serious events: 6 serious events

Other events: 14 other events

Deaths: 0 deaths

Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib

Serious events: 33 serious events

Other events: 57 other events

Deaths: 50 deaths

Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo

Serious events: 39 serious events

Other events: 53 other events

Deaths: 45 deaths

Phase 2: Placebo + Carboplatin/Etoposide -> Placebo

Serious events: 27 serious events

Other events: 53 other events

Deaths: 41 deaths

Serious adverse events

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 participants at risk Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 participants at risk Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 participants at risk Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 participants at risk Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=8 participants at risk Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide n=14 participants at risk Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide n=4 participants at risk Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib n=60 participants at risk Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo n=58 participants at risk Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Placebo + Carboplatin/Etoposide -> Placebo n=60 participants at risk Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders ANAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.1% 7/58 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders LEUKOPENIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.9% 4/58 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders PANCYTOPENIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	10.3% 6/58 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders ACUTE MYOCARDIAL INFARCTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders CARDIAC FAILURE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders CARDIO-RESPIRATORY ARREST	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders MYOCARDIAL INFARCTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders SINUS NODE DYSFUNCTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders VENTRICULAR TACHYCARDIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Endocrine disorders DIABETES INSIPIDUS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders GASTROINTESTINAL INFLAMMATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Endocrine disorders INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders COLITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders DIARRHOEA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders DUODENAL ULCER PERFORATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders GASTRIC PERFORATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders GASTRITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders HAEMATEMESIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ILEUS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders INTESTINAL ISCHAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders MOUTH HAEMORRHAGE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders NAUSEA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders PALATAL OEDEMA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders VOMITING	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders ASTHENIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders CHEST PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders DEATH	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders DISEASE PROGRESSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders FATIGUE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders MALAISE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders OEDEMA PERIPHERAL	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders PYREXIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders SUDDEN CARDIAC DEATH	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders SUDDEN DEATH	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Hepatobiliary disorders HEPATIC FAILURE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations ABDOMINAL SEPSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations ANAL ABSCESS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations BRONCHITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations CELLULITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations DEVICE RELATED INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations ENCEPHALITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations IMPLANT SITE CELLULITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations ORCHITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations PLEURAL INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations PNEUMONIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	11.7% 7/60 • Number of events 10 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations PNEUMONIA INFLUENZAL	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations PNEUMONIA LEGIONELLA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders ARTHRALGIA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations SEPSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations SEPTIC SHOCK	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications VASCULAR PROCEDURE COMPLICATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations PLATELET COUNT DECREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations TRANSAMINASES INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders DECREASED APPETITE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders BURSITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.6% 5/58 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.9% 4/58 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders CEREBRAL ISCHAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders DIZZINESS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders HEADACHE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders ISCHAEMIC STROKE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders HAEMORRHAGE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders MIGRAINE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders MOTOR DYSFUNCTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders TOXIC NEUROPATHY	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders DEPRESSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders ACUTE KIDNEY INJURY	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders PULMONARY HAEMORRHAGE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders AORTITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders HYPOTENSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders PERIPHERAL ARTERY THROMBOSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders PERIPHERAL EMBOLISM	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders SUPERIOR VENA CAVA SYNDROME	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders VENA CAVA THROMBOSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.

Other adverse events

Measure	Phase 1: Veliparib 80 mg BID 7 Days + Carboplatin/Etoposide n=4 participants at risk Participants received 80 mg veliparib orally twice a day (BID) on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered intravenously (IV) on Day 1 at a target area under the curve (AUC) 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 120 mg BID 7 Days + Carboplatin/Etoposide n=3 participants at risk Participants received 120 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 160 mg BID 7 Days + Carboplatin/Etoposide n=4 participants at risk Participants received 160 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 200 mg BID 7 Days + Carboplatin/Etoposide n=3 participants at risk Participants received 200 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 7 Days + Carboplatin/Etoposide n=8 participants at risk Participants received 240 mg veliparib orally BID on Days -2 to 5 (7 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 5 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 14 Days + Carboplatin/Etoposide n=14 participants at risk Participants received 240 mg veliparib orally BID on Days -2 to 12 (14 days) in combination with carboplatin/etoposide for up to four 21-day cycles, with the exception of Cycle 2, when veliparib was administered on Days 2 to 12 to allow for evaluation of potential impact of veliparib on etoposide pharmacokinetics. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 1: Veliparib 240 mg BID 21 Days + Carboplatin/Etoposide n=4 participants at risk Participants received 240 mg veliparib orally BID on Days -2 to Day 19 (continuous schedule) in combination with carboplatin/etoposide for up to four 21-day cycles. Carboplatin was administered IV on Day 1 at a target AUC 5 mg/mL\*minute and etoposide 100 mg/m² IV on Days 1 to 3 of every 21-day cycle. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Veliparib n=60 participants at risk Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression continued on veliparib monotherapy at 400 mg BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Veliparib + Carboplatin/Etoposide -> Placebo n=58 participants at risk Participants received veliparib 240 mg BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min administered on Day 1, and etoposide 100 mg/m² administered on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.	Phase 2: Placebo + Carboplatin/Etoposide -> Placebo n=60 participants at risk Participants received placebo BID on Day -2 to 12 (14-day schedule), carboplatin AUC 5 mg/mL\*min on Day 1, and etoposide 100 mg/m² on Days 1 to 3 of each 21-day cycle for up to 6 cycles. Participants without evidence of disease progression received placebo monotherapy BID continuous dosing (21-day cycles) until disease progression or unacceptable toxicity.
Blood and lymphatic system disorders ANAEMIA	25.0% 1/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 4/8 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 7/14 • Number of events 18 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	58.3% 35/60 • Number of events 104 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	60.3% 35/58 • Number of events 105 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	43.3% 26/60 • Number of events 55 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders DISSEMINATED INTRAVASCULAR COAGULATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders LEUKOPENIA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	11.7% 7/60 • Number of events 15 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	20.7% 12/58 • Number of events 27 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 13 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders NEUTROPENIA	25.0% 1/4 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 4/8 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	57.1% 8/14 • Number of events 34 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	60.0% 36/60 • Number of events 94 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	56.9% 33/58 • Number of events 86 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	46.7% 28/60 • Number of events 71 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders THROMBOCYTOPENIA	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	35.7% 5/14 • Number of events 16 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	36.7% 22/60 • Number of events 58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	39.7% 23/58 • Number of events 62 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	20.0% 12/60 • Number of events 22 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.6% 5/58 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders LEFT VENTRICULAR FAILURE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders PALPITATIONS	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Cardiac disorders TACHYCARDIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders EAR DISCOMFORT	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders HYPOACUSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders OTOTOXICITY	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Ear and labyrinth disorders TINNITUS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Endocrine disorders INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Eye disorders BLINDNESS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Eye disorders DRY EYE	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Eye disorders EYE IRRITATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Eye disorders EYE PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Eye disorders LACRIMATION INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Eye disorders VITREOUS DETACHMENT	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ANAL INFLAMMATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ASCITES	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders CONSTIPATION	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	23.3% 14/60 • Number of events 17 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	22.4% 13/58 • Number of events 19 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	18.3% 11/60 • Number of events 15 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders DIARRHOEA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 7/14 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	13.3% 8/60 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	19.0% 11/58 • Number of events 21 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	18.3% 11/60 • Number of events 12 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders DIVERTICULUM	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders DRY MOUTH	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	28.6% 4/14 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders DYSPEPSIA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	11.7% 7/60 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ENTEROVESICAL FISTULA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ERUCTATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders FLATULENCE	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders GASTRITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders GASTROOESOPHAGEAL REFLUX DISEASE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders RETCHING	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders HAEMATOCHEZIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders HAEMORRHOIDS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders NAUSEA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	62.5% 5/8 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	64.3% 9/14 • Number of events 16 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	48.3% 29/60 • Number of events 57 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	39.7% 23/58 • Number of events 47 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	35.0% 21/60 • Number of events 29 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders OESOPHAGITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ORAL DISCOMFORT	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders PROCTALGIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders PROCTITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders STOMATITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Gastrointestinal disorders VOMITING	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	75.0% 3/4 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	21.7% 13/60 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	17.2% 10/58 • Number of events 12 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	13.3% 8/60 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders ASTHENIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	15.0% 9/60 • Number of events 16 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	19.0% 11/58 • Number of events 26 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders CHEST PAIN	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders CREPITATIONS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders CRYING	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders FACE OEDEMA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders FATIGUE	50.0% 2/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	100.0% 3/3 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	75.0% 6/8 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	64.3% 9/14 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 15/60 • Number of events 23 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	27.6% 16/58 • Number of events 17 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	16.7% 10/60 • Number of events 12 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders FEELING ABNORMAL	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders FEELING COLD	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders GAIT DISTURBANCE	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders INJECTION SITE EXTRAVASATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders INJECTION SITE HAEMATOMA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders INJECTION SITE PHLEBITIS	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders LOSS OF CONTROL OF LEGS	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders MALAISE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders MUCOSAL INFLAMMATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders NECROSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders OEDEMA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders OEDEMA PERIPHERAL	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	10.3% 6/58 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders PYREXIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	10.0% 6/60 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	13.3% 8/60 • Number of events 10 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders SWELLING	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
General disorders SWELLING FACE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Hepatobiliary disorders HEPATIC PAIN	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Immune system disorders DRUG HYPERSENSITIVITY	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations BRONCHITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations CLOSTRIDIUM DIFFICILE COLITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations CYSTITIS	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations DEVICE RELATED INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations GASTROENTERITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations NASOPHARYNGITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations ORAL CANDIDIASIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.9% 4/58 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations ORAL FUNGAL INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations PNEUMONIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations RHINITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations TOOTH ABSCESS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Infections and infestations URINARY TRACT INFECTION	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications CHEMICAL PHLEBITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications FOREARM FRACTURE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications MUSCLE RUPTURE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications MUSCLE STRAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications POST PROCEDURAL COMPLICATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications PROCEDURAL HEADACHE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications PROCEDURAL PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications SKIN ABRASION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 10 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations BLOOD CREATININE INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations GAMMA-GLUTAMYLTRANSFERASE INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations HLA MARKER STUDY POSITIVE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations INTERNATIONAL NORMALISED RATIO INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations LYMPHOCYTE COUNT DECREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations NEUTROPHIL COUNT DECREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	42.9% 6/14 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations PLATELET COUNT DECREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	35.7% 5/14 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations TRANSAMINASES INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations URINE OUTPUT DECREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations WEIGHT DECREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	35.7% 5/14 • Number of events 13 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	11.7% 7/60 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations WEIGHT INCREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders DECREASED APPETITE	50.0% 2/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	75.0% 3/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 7/14 • Number of events 16 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	28.3% 17/60 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	20.7% 12/58 • Number of events 14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	23.3% 14/60 • Number of events 16 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders DEHYDRATION	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	10.3% 6/58 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	10.0% 6/60 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPOCALCAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPOKALAEMIA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	15.5% 9/58 • Number of events 13 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	11.7% 7/60 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	28.6% 4/14 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	16.7% 10/60 • Number of events 24 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.1% 7/58 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	15.0% 9/60 • Number of events 12 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	10.0% 6/60 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.1% 7/58 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders ARTHRALGIA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	10.0% 6/60 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders BACK PAIN	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	42.9% 6/14 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	15.0% 9/60 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.1% 7/58 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	15.0% 9/60 • Number of events 9 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders COCCYDYNIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders GROIN PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders INTERVERTEBRAL DISC PROTRUSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL STIFFNESS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders MYALGIA	75.0% 3/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	14.3% 2/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders MYOSITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	28.6% 4/14 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.9% 4/58 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders PAIN IN JAW	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders SPINAL PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders TENDON PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CANCER PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) METASTASES TO CENTRAL NERVOUS SYSTEM	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders ATAXIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders DISTURBANCE IN ATTENTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders DIZZINESS	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.3% 5/60 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	15.5% 9/58 • Number of events 13 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders DYSARTHRIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders DYSGEUSIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.9% 4/58 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders HEAD DISCOMFORT	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders HEADACHE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	16.7% 10/60 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	15.5% 9/58 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	11.7% 7/60 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders MEMORY IMPAIRMENT	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders MUSCLE CONTRACTIONS INVOLUNTARY	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders NEUROPATHY PERIPHERAL	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders POLYNEUROPATHY	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders PRESYNCOPE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders SOMNOLENCE	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Nervous system disorders TREMOR	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Product Issues DEVICE OCCLUSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders ANXIETY	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 2/8 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.9% 4/58 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders CONFUSIONAL STATE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders DELIRIUM	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders DEPRESSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders HALLUCINATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders INSOMNIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 7/14 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.6% 5/58 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders RESTLESSNESS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Psychiatric disorders TENSION	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders DYSURIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders NOCTURIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders PNEUMATURIA	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders POST MICTURITION DRIBBLE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders TUBULOINTERSTITIAL NEPHRITIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders URINARY HESITATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Renal and urinary disorders URINARY RETENTION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Reproductive system and breast disorders PERINEAL PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders COUGH	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	35.7% 5/14 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	10.0% 6/60 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.6% 5/58 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	11.7% 7/60 • Number of events 7 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders DYSPHONIA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	50.0% 2/4 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	35.7% 5/14 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	20.0% 12/60 • Number of events 16 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	15.5% 9/58 • Number of events 11 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	11.7% 7/60 • Number of events 10 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders HICCUPS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	25.0% 1/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.9% 4/58 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.4% 2/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders ALOPECIA	50.0% 2/4 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	50.0% 2/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	66.7% 2/3 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	37.5% 3/8 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	57.1% 8/14 • Number of events 12 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	36.7% 22/60 • Number of events 27 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	29.3% 17/58 • Number of events 19 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	30.0% 18/60 • Number of events 20 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders ECCHYMOSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders ECZEMA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	21.4% 3/14 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders NIGHT SWEATS	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders PETECHIAE	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders PIGMENTATION DISORDER	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders PRURITUS	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders RASH	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	6.7% 4/60 • Number of events 4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders RASH MACULAR	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	12.5% 1/8 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders SKIN ULCER	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders STICKY SKIN	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders HAEMATOMA	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders HOT FLUSH	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.2% 3/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders HYPERTENSION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	28.6% 4/14 • Number of events 6 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/58 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	5.0% 3/60 • Number of events 3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders HYPOTENSION	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	33.3% 1/3 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	7.1% 1/14 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	1.7% 1/60 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	8.6% 5/58 • Number of events 5 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	3.3% 2/60 • Number of events 2 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.
Vascular disorders INTERMITTENT CLAUDICATION	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	25.0% 1/4 • Number of events 1 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/3 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/8 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/14 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/4 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/58 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.	0.00% 0/60 • All-cause mortality is reported from enrollment to the end of study, maximum time on follow-up was 26 months. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 30 days after the last dose of study drug; Maximum duration of treatment in Phase 1 was 541 days and maximum duration of treatment in Phase 2 was 654 days. All-cause mortality is reported for all participants enrolled in Phase 1 and randomized in Phase 2. Adverse events are reported for all participants who received at least 1 dose of study drug.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER